6 F153 Meds

Women's Health Initiative Observational Study (NHLBI)

F153 Meds

OS Participants

OMB: 0925-0414

Document [pdf]
Download: pdf | pdf
WHI

Ver. 1
OMB #0925-0414 Exp: XX/XXXX

Form 153 – Medication and Supplement Inventory
WHI Extension Study
Date Received:

-

Reviewed By:

-

-

- Affix label here-

(MM/DD/YY)

Participant ID: __ __

__ __ - ___ ___ ___ - ___

First Name ________________________M.I._____
Last Name _________________________________

Contact Type:

1 Phone
2 Mail
8 Other

Visit Type:

3 Annual
4 Non-Routine

FCA
Language:

OUI

OU2

1 English 2 Spanish

OFFICE USE ONLY
Public reporting burden for this collection of information is estimated to average 20 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any
other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705
Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0414). Do not return the completed form to this address.

Instructions:
To help us learn about the health of WHI participants, we would like to know
about the medications and supplements you take.
This form asks about all of the prescription medications you are currently taking,
and some of the over-the-counter medications and dietary supplements you may
be taking.
If you would like to have a WHI staff member at the Clinical Coordinating Center
complete this form with you over the phone, please feel free to call 1-800-218-8415.

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WHI

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Ver. 1

Section A: Prescription Medications
This first section asks about prescription medications you are currently taking. This includes medications
that you only take as needed, such as nitroglycerin. A prescription medication is one that is written (or
phoned in) by your health care provider and must be filled at a pharmacy or drug store.
1. Are you currently taking any medications that require a prescription from a doctor or health care
provider?
0 No Go to Section B on Page 6

1 Yes

Continue below

For this section, you will need information from the labels on bottles or packaging that your prescription
medications came in. To get started, please gather together all of your prescription medications so that
this information is readily available as you complete the form. These medications may be in your
medicine cabinet, refrigerator, or purse. It is important to include all of your prescriptions.
For each prescription medication, please answer the questions on the next page, including the
medication’s name and strength. You will find this information on the label of the pill bottle or
container. An example of a prescription label and a completed medication question are shown below.
Example of a prescription label
Walgreens, Seattle, WA 98028
(DD/) Ph: 866-254-1669
RX#4599773 Sept. 6, 2005 Fill 1 of 1

On the example prescription label,
the medication name Phenytoin
NA (Dilantin), strength 100 MG,
and type CAP are all on one line.

DOE, JANE 206-566-0442
Take one capsule by mouth as directed in
morning and at bedtime
Discard after Sept. 6, 2006 Mfr________
Qty: 60 CAP Kroll, Phil MD
Phenytoin NA (Dilantin) 100 MG CAP

Example of a completed question using the label example above
Prescription Medication
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)

Write in Information Below:

About how long have you been taking this
medication? (If you’re not sure, please use
your best guess.)

1 Less than 1 month
2 1 to12 months

PHENYTOIN NA (DILANTIN)
100 MG
CAPSULE

3

More than 1 year

Please go to next page
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How many years?

03

WHI

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Ver. 1

2. For each of the prescription medications you are currently taking, please answer the questions below
using the label on the prescription bottle. Please print clearly. You can use your best estimate about
how long you have been taking the medication.
Complete all of the information in the table for each medication you take. There are enough boxes to
write up to 10 different medications. When you have completed the information for all of your
prescription medications, please go to Section B of the questionnaire on page 6.
Prescription Medication #1
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use
your best guess.)

Prescription Medication #2
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use
your best guess.)

Prescription Medication #3
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use
your best guess.)

Write in Information Below:

1 Less than 1 month
2 1 to12 months
3 More than 1 year

How many years?

Write in Information Below:

1 Less than 1 month
2 1 to12 months
3 More than 1 year

How many years?

Write in Information Below:

1 Less than 1 month
2 1 to12 months
3 More than 1 year

How many years?

Continue on the next page, or go to Section B on page 6 if you have listed all your medications
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WHI

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Prescription Medication #4
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use your
best guess.)

Prescription Medication #5
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use your
best guess.)
Prescription Medication #6
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use your
best guess.)
Prescription Medication #7
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use your
best guess.)

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Ver. 1

Write in Information Below:

1 Less than 1 month
2 1 to12 months
3 More than 1 year

How many years?

Write in Information Below:

1 Less than 1month
2 1 to12 months
3 More than 1 year

How many years?

Write in Information Below:

1 Less than 1 month
2 1 to12 months
3 More than 1 year

How many years?

Write in Information Below:

1 Less than 1 month
2 1 to12 months
3 More than 1 year

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How many years?

WHI

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Prescription Medication #8
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use
your best guess.)

Prescription Medication #9
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use
your best guess.)
Prescription Medication #10
Name of the medication
(as written on label)
Strength of the medication
(as written on label)
Medication type (examples: capsule, tablet,
cream, liquid, suppository, inhaler, injection)
About how long have you been taking this
medication? (If you’re not sure, please use
your best guess.)

Ver. 1

Write in Information Below:

1 Less than 1 month
2 1 to12 months
3 More than 1 year

How many years?

Write in Information Below:

 Less than 1 month
2 1 to12 months
3 More than 1 year
1

How many years?

Write in Information Below:

1 Less than 1 month
2 1 to12 months
3 More than 1 year

How many year s?

Continue on the next page, or go to Section B on page 6 if you have listed all your medications

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WHI

3.

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Ver. 1

In the previous question there was room to write up to 10 prescription medications. If you take
more than 10, please list the names of those medications below. List only their names, and do not
include any medications you already told us about in the prescription medications table. You may
receive a call from the WHI Clinical Coordinating Center to gather more detailed information on
these medications. If you do not take more then 10, skip to question 4.
a.__________________________________

f. ____________________________________

b.__________________________________

g. ____________________________________

c. __________________________________

h. ____________________________________

d. __________________________________

i. ____________________________________

e. __________________________________

j. ____________________________________

Section B: Barriers to Prescription Medications
4. Have any of the following barriers prevented you from obtaining or taking any medications that have
been prescribed for you? (Please check all that apply.)

1 My health insurance would not cover the medication.
2 The medication or copayment cost too much.
3 It is a problem for me to get to the medical facility/physician.
4 Taking the medication would be inconvenient.
5 I was concerned about possible side effects or complications from the medication.
6 I was concerned about missing work due to taking the medication.
7 My family discouraged me from taking the medication.
8 My friends discouraged me from taking the medication.
9 I am taking too many medications.
10 I don’t like taking medications.
0 I have not experienced any barriers to taking prescription medications.
Please go to next page
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WHI

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Ver. 1

Section C: Non-Prescription Medications
The next set of questions ask about certain non-prescription medicines you have taken at least once
a week in the past two weeks. These are medicines that you can buy over-the-counter without a
prescription from your health care provider.

5. Please answer the following questions about the non-prescription medicines listed below. For
each type of medicine that you are taking, please write in the name and strength from the product
label, how often you take it, and how long you have taken it. For some types listed below, there
is space to write in two products. If you are taking more than two, please write in just the
two products that you take most often. Note that the brand names provided below are just
examples; write in the brand of the medicine you are taking.
5.1 Are you taking Aspirin, for example, Bayer, St. Josephs, Bufferin, Anacin, Excedrin, BC powder,
baby aspirin, Doan’s? (This does not include aspirin-free drugs such as Tylenol or Advil.)

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle or package)
____________________________

0 No

____________________________
Strength: ___________________

How long have you
been taking it?

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
4 Once a week
Number of years?
1-3
days
a
month
5

5.2 Are you taking Anti-Inflammatory pain medicines, such as Advil, Aleve, Ibuprofen, Motrin,
Naprosyn, Naproxen, Nuprin, Anaprox, or Orudis KT?

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle or package)
___________________________

0 No

___________________________
Strength: __________________

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
4 Once a week
Number of years?
5 1-3 days a month

Please go to next page
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How long have you
been taking it?

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WHI

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Ver. 1

5.3 Are you taking a second type of Anti-Inflammatory pain medicine?

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle or package)
___________________________

0 No

___________________________
Strength: __________________

How long have you
been taking it?

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
4 Once a week
Number of years?
1-3
days
a
month
5

5.4 Are you taking an Antacid or heartburn medicine, such as Axid, Pepcid AC, Prilosec, Tagamet,
Zantac, Cimetidine, Famotidine, Omeprazole, or Ranitidine?

1 Yes

Name of the product
(listed on the bottle or package)
___________________________

0 No

___________________________
Strength: __________________

How often do
you take it?
1 Once a day or more
2 4-6 days a week
3 2-3 days a week
4 Once a week
5 1-3 days a month

How long have you
been taking it?

1 Less than 1 month
2 1 to 12 months
3 More than 1 year
Number of years?

5.5 Are you taking a second type of Antacid or heartburn medicine?

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle or package)
___________________________

0 No

___________________________
Strength: __________________

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
4 Once a week
Number of years?
5 1-3 days a month

Please go to next page
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How long have you
been taking it?

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WHI

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Ver. 1

5.6 Are you taking natural female hormones, herbal estrogens, or phytoestrogens, such as Remifemin,
DHEA pills, wild yam, soy or flax products, dong quai, or black cohosh?

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle or package)
___________________________

0 No

___________________________
Strength: __________________

How long have you
been taking it?

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
4 Once a week
Number of years?
5 1-3 days a month

5.7 Are you taking a second type of natural female hormones, herbal estrogens, or phytoestrogens?

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle or package)
___________________________

0 No

___________________________
Strength: __________________

6.

How long have you
been taking it?

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
4 Once a week
Number of years?
5 1-3 days a month

In most states, some types of insulin can be purchased over-the-counter without a prescription. If you
are currently taking insulin and you haven’t included it on the list of your prescription medicines in
Section A, please write it in question 6.1 below.

6.1 Are you taking over-the-counter insulin? If you listed insulin as a prescription medication in
Section A, do not include it again here.

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle or package)
___________________________

0 No

___________________________

1 Once a day or more 1 Less than 1 month
2 Less than once a day 2 1 to 12 months
3 More than 1 year
Number of years?

Strength: __________________

Please go to next page
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How long have you
been taking it?

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WHI

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Ver. 1

Section D: Dietary Supplements
In this final section, we ask about certain vitamin or mineral supplements you have taken at least once a
week in the past two weeks.
7. Please answer the following questions about the vitamin or mineral supplements listed below. For
each vitamin supplement that you are taking, please write in the name from the bottle/package, how
often, and how long you have been taking it. Although you may be taking other supplements at this
time, we are asking only for information on the supplements listed.

7.1 Are you taking a Daily Multi-Vitamin Supplement that has 10 or more vitamins and/or minerals
in one pill? Examples are One-A-Day, Centrum, Theragran, Geritol.

1 Yes

___________________________

0 No

How often do
you take it?

Product name and/or brand
(listed on the bottle)

___________________________
___________________________

How long have you
been taking it?

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
4 Once a week
Number of years?

7.2 Are you taking Calcium/Vitamin D supplement mixture? This is a pill that contains both Calcium
and Vitamin D, but not in a multi-vitamin with several vitamins and minerals.

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle)
___________________________

0 No

___________________________
Calcium
Strength: __________________

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
Number of years?
4 Once a week

Vitamin D
Strength: _________________

Please go to next page
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How long have you
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WHI

Form 153 – Medication and Supplement Inventory
WHI Extension Study

Ver. 1

7.3 Ar e you taking Calcium as a single mineral supplement containing no other vitamins or minerals?

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle)
___________________________

0 No

___________________________
Strength: ___________________

How long have you
been taking it?

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
4 Once a week
Number of years?

7.4 Are you taking Vitamin D (Calcifer ol) as a single vitamin supplement containing no other vitamin or
mineral?

1 Yes

How often do
you take it?

Name of the product
(listed on the bottle)
___________________________

0 No

___________________________
Strength: __________________

8. What is the date that you completed this form?

How long have you
been taking it?

1 Once a day or more 1 Less than 1 month
2 4-6 days a week 2 1 to 12 months
3 2-3 days a week 3 More than 1 year
4 Once a week
Number of years?

Month

Day

Year

Thank you.
Please take a moment to review
any questions you may have missed.

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Form 153 – Medication and Supplement Inventory
WHI Extension Study
S p a n i s h

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t r a n s l a t i o n

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u n d e r

Ver. 1

w a y

WHI Extension Study - Form 153 - Medication and Supplement Inventory (Ver. 1)

Page 1

FORM:

153 – MEDICATION AND SUPPLEMENT INVENTORY

Version:

1 – November, 2008

Description:

Self-administered or interviewer-administered; 9-page booklet; key-entered at the Clinical
Coordinating Center (CCC).

When used:

Collected one time as part of the annual contacts for Clinical Trial (CT) and Observational Study (OS)
participants enrolled in the WHI Extension Study. Completed at a non-routine contact when a
participant death is reported.

Purpose:

To collect updated information on the prescription and over-the-counter medications and nutritional
supplements currently being used by participants.

GENERAL INSTRUCTIONS
1.

The form is printed in both English (Form 153) and Spanish (Form 153S) versions.

2.

The Form 153 for WHI Extension Study participants will be labeled and mailed from the CCC directly to the
participant.
•

3.

The CCC mails the form to the participant and asks her to mail it back in a return envelope by a specified date.
Following the CCC mailing, if the participant does not return the Form 153 within 3 months of the first
mailing, it will be sent again. If the form is not returned within 2 months of the second mailing, the form will
be sent a third time. If the form is still not returned, CCC staff will contact the participants by telephone to
collect the information from willing participants. The CCC will data enter the forms, and will use the Medispan
database to code medications during the data entry process.

In the event that this form is collected by FC staff, the form should be sent to the CCC for data entry.

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Page 2

Item Instructions
Cover page
1.

Date Received

Fill in date received at the CCC.

2.

Reviewed By

Fill in standard 3-digit WHI employee ID of staff member reviewing the form for
data entry.

3.

Contact Type

Mark appropriate box (phone, mail, other).

Prescription Medications
1.

Currently Taking
Prescription Medications

No/Yes. Participants indicating “No” skip to Q 4 in Section B.

2a.

Prescription Medication
Name

For each prescription medication listed, participant records the name of the
medication.

2b.

Prescription Medication
Strength

For each prescription medication listed, participant records the strength of the
medication.

2c.

Prescription Medication
Type

For each prescription medication listed, participant records the medication type,
e.g., capsule, tablet, cream, liquid, suppository, inhaler, injection.

2d.

Prescription Medication
Duration

For each prescription listed, participant indicates length of time taking medication.
Response choices are: 1. Less than a month; 2. 1-12 months; 3. More than 1 year.
Those indicating response 3 provide the actual number of years.

Repeat 2a-d for each prescription medication, up to 10 medications.
3.

Other Prescription
Medications

Participant records name of any other prescription medications they are taking, if
there was not enough room to list them in item 2 above.

4.

Barriers to Prescription
Medications

Participant checks all barriers that apply.

Non-Prescription Medications
Participant indicates the following information for each of these non-prescription medications: aspirin, antiinflammatories, antacid or heartburn medicines, and natural female hormones. Participants can list up to 2 types of antiflammatories, antacids, and natural hormones.
5.

Taken the NonPrescription Medication
in Past Two Weeks

Yes/No. Participants indicating “No” skip to the next non-prescription medication.

5.

Name of the NonPrescription Medication

For each medication they are taking, participant provides the name of the product.

5.

Strength of the NonPrescription Medication

For each medication they are taking, participant provides the strength of the
product.

5.

Non-Prescription
Medication – Frequency

5.

Prescription Medication
Duration

For each medication they are taking, participant indicates how often they take it.
The options are: 1. Once a day or more; 2. 4-6 days a week; 3. 2-3 days a week; 4.
Once a week; 5. 1-3 days a month.
For each medication they are taking, participant indicates how long they have been
taking it. Response choices are: 1. Less than a month; 2. 1-12 months; 3. More
than 1 year. Those indicating response 3 also indicate the actual number of years.

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6.

Over-the-Counter Insulin

Page 3

Participants are asked if they are taking over-the-counter insulin Yes/No. Those
who indicate yes, are asked to provide the name of the product, the strength, how
often it is taken (1. Once a day or more; 2. Less than once a day) and how long it
has been taken (1. Less than a month; 2. 1-12 months; 3. More than 1 year. How
many years?)

Dietary Supplements
7
M/V.

7
Cal/
VitD.

7
Cal.

Daily Multi-Vitamin
Supplement – Taken in
Past 2 Weeks

Yes/No. Participants indicating “No” skip to the next supplement.

Daily Multi-Vitamin
Supplement – Product
Name

Participant provides the name of the product.

Daily Multi-Vitamin
Supplement – Frequency

Participant indicates how often they take it. The options are: 1. Once a day or
more; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week.

Daily Multi-Vitamin
Supplement – Duration

Participant indicates how long they have been taking it. Response choices are: 1.
Less than a month; 2. 1-12 months; 3. More than 1 year. Those indicating response
3 also indicate the actual number of years.

Calcium/Vitamin D
Supplementation Mixture
– Taken in Past 2 Weeks

Yes/No. Participants indicating “No” skip to the next supplement.

Calcium/Vitamin D
Supplementation Mixture
– Product Name

Participant provides the name of the product.

Calcium/Vitamin D
Supplementation Mixture
– Strength

Participant provides strength of calcium and strength of vitamin D.

Calcium/Vitamin D
Supplementation Mixture
– Frequency

Participant indicates how often they take it. The options are: 1. Once a day or
more; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week.

Calcium/Vitamin D
Supplementation Mixture
– Duration

Participant indicates how long they have been taking it. Response choices are: 1.
Less than a month; 2. 1-12 months; 3. More than 1 year. Those indicating response
3 also indicate the actual number of years.

Calcium Single
Supplement – Taken in
Past 2 Weeks

Yes/No. Participants indicating “No” skip to the next supplement.

Calcium Single
Supplement – Product
Name

Participant provides the name of the product.

Calcium Single
Supplment - Strength

Participant provides strength of calcium.

Calcium Single
Supplement – Frequency

Participant indicates how often they take it. The options are: 1. Once a day or
more; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week.

Calcium Single
Supplement – Duration

Participant indicates how long they have been taking it. Response choices are: 1.
Less than a month; 2. 1-12 months; 3. More than 1 year. Those indicating response
3 also indicate the actual number of years.

I153V1.DOC 12/01/08

WHI Extension Study - Form 153 - Medication and Supplement Inventory (Ver. 1)

7
VitD.

8.

Page 4

Vitamin D Single
Supplement – Taken in
Past 2 Weeks

Yes/No. Participants indicating “No” skip to the next supplement.

Vitamin D Single
Supplement – Product
Name

Participant provides the name of the product.

Vitamin D Single
Supplment - Strength

Participant indicates strength of the vitamin D.

Vitamin D Single
Supplement – Frequency

Participant indicates how often they take it. The options are: 1. Once a day or
more; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week.

Vitamin D Single
Supplement – Duration

Participant indicates how long they have been taking it. Response choices are: 1.
Less than a month; 2. 1-12 months; 3. More than 1 year. Those indicating response
3 also indicate the actual number of years.

Date

Month/Day/Year the form was completed.

I153V1.DOC 12/01/08


File Typeapplication/pdf
File TitleVer 8
AuthorWHI
File Modified2009-12-17
File Created2009-12-17

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