Att 17D_Study Salt Procedures for Study Staff_01082014

Form Approved

OMB No. 0920-0982

Expiration date: 09/30/2015

Study Salt Procedures for Study Staff

Public reporting burden of this collection of information is estimated to average 5 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  CDC/ATSDR Reports Clearance Officer, 1600 Clifton Road, NE, M/S D74, Atlanta, GA 30333, ATTN: PRA 0920-0982.

Overview

Participants in the sub study will be asked to use Study Salt – instead of regular household salt - in all home cooking and when adding salt at the table at home and away from home. This procedure will start the day the participant turns in their first 24-hour urine sample and will conclude the day they return their last 24-hour urine sample. The study will provide each participant with a salt shaker containing the Study Salt for use during this time period. The shaker will be weighed before distribution to the participant and upon return. This information will be recorded by clinic staff on the ‘Study Salt Record’ form.

Distribution of Study Salt Set

At the baseline clinic visit the Study Salt procedure will be explained to the participant (see ‘Study Orientation for Sub Study Participants’). When the participant returns his/her first 24 hour urine sample to the clinic, two salt shakers containing Study Salt will be given to the participant along with written instructions (‘Study Salt Instructions for Participants’). Prior to distributing the lithium salt set clinic staff will make sure the set is labeled with the participant ID and the weight of the shaker prior to distribution is recorded on the ‘Study Salt Record’ form.

Study Salt Sets

Each set will include the following:

• Glass salt shaker labeled “Table Salt” containing approximately ¼ cup of Study Salt with participant ID label affixed to it

• Glass salt shaker labeled “Cooking Salt” containing approximately ¼ cup of Study Salt with participant ID label affixed to it

Collection

Participants will be asked to return the salt shakers to the clinic when they return their final 24-hour urine sample. The ‘Study Salt Questionnaire’ will also be completed at that time.