Pilot Testing on New NHANES 2009-10 Content

Attachment K.

Protocol for 24 Hour Urine Sodium Validation Study (ages 20-79)

National Health and Nutrition Examination Survey (NHANES)

24 Hour Urine Sodium Validation Study

OMB no. 0920-0237

Expires: 12/31/2011

Assurance of confidentiality – All information which would permit identification of an

individual, a practice, or an establishment will be held confidential, will be used for

statistical purposes only by NCHS staff, contractors, and agents only when required and with necessary controls, and will not be disclosed or released to other persons without the consent of the individual or establishment in accordance with section 308(d) of the Public Health Service Act (42 USC 242m) and the Confidential Information Protection and Statistical Efficiency Act (PL-107-347).

Public reporting burden of this collection of information is estimated to average 1.5 hours 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, MS D-74, Atlanta, GA 30333. ATTN: PRA (0920-0237).

24 Hour Urine Sodium Validation Study Protocol:

Eligibility: Ages 20-79 (with 1/3 in each of these age groups—20-39-40-59, 60-79), equal numbers of both genders, and including non-Hispanic Blacks and the Hispanic population.

Informed Consent: Written informed consent will be obtained.

Exclusion Criteria: Pregnant women, persons who take diuretics, medicine for high blood pressure, ACE inhibitors, or angiotensin receptor blockers and those with renal disease will be excluded from this study.

Study Design: Paid volunteers will be recruited and initially screened for inclusion and exclusion criteria via telephone. If they meet the criteria and are willing to participate they will come to a central location, the NHANES home office. At the home office, participants will receive instructions and supplies, and venipuncture, height, weight and blood pressure measurements and a dietary recall will be obtained. After leaving the home office, participants will collect their urine for 24 hours, during the course of a normal day. They will be asked to use a separate container for each collection. After urine collection, participants will return their specimens to the NHANES home office and a dietary recall will be obtained for the 24 hours that their urine was collected.

Data Collection: Venipuncture, height, weight and blood pressure measurements, before the urine collection, and both dietary recalls will be obtained at the NHANES home office. Participants will do urine collections on their own, during the normal course of their day.

Report of Findings: The participants will be given their blood pressure measurement and the results of the venipuncture.