Att 17D_Study Salt Supplement Procedures for Study Staff

Form Approved

OMB No. 0920-xxxx

Exp. Date xx/xx/xxxx

Study Salt Supplement 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-xxxx.

Overview

Participants in the sub study will be asked to use a study salt supplement – instead of your 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 and bottle containing the study salt for use during this time period. The shaker and bottle will be weighed before distribution to the participant and upon return. This information will be recorded by clinic staff on the ‘Study Salt Supplement’ form.

Distribution of Study Salt Supplement Set

At the baseline clinic visit the Study Salt Supplement procedure will be explained to the participant (see ‘Study Salt Supplement Baseline Clinic Visit Instructions’). When the participant returns his/her first 24 hour urine sample to the clinic a salt shaker and bottle containing Study Salt Supplement will be given to the participant along with written instructions (‘Study Salt Supplement Instructions’) and a ‘Study Salt Supplement Questionnaire’. 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 and bottle prior to distribution is recorded on the ‘Study Salt Supplement Record’ form.

Study Salt Supplement Sets

Each set will include the following:

• Small sturdy paper bag with handle labeled with participant ID

• Plastic salt shaker containing approximately 100 grams (about 7 tablespoons) of Study Salt Supplement with participant ID label affixed to it

• Plastic container containing approximately 150 grams (about 10 tablespoons) of Study Salt Supplement with participant ID label affixed to it

• Instruction sheet

• Study Salt Supplement Questionnaire

Collection

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