#2900: Nutrient and Drug Study

Purpose
The purpose of this study is to examine whether a multivitamin/mineral supplement will improve nutritional status in older adults at increased risk of micronutrient inadequacy induced by drugs commonly used by this population, specifically diuretics, oral hypoglycemic medications, and stomach acid reducing medications. Participants will be asked to consume one of multivitamin/mineral supplements provided by the Center for 16 weeks, and have blood and urine samples collected 4 times during the study.

Target Population
Men and women, ages 45 -75 years old

Major Exclusions
• BMI <20 or >36 kg/m2
• Vegetarians or vegans
• Pregnant or intend to be pregnant
• Active treatment for cancer of any type >1 y
• Daily alcohol intake of >14 drinks/wk (168 oz beer, 56 oz wine, 14 oz hard liquor)
• Regular use of any dietary supplements containing vitamins and minerals; however, subjects who are willing to refrain from the use of these supplements for 1 mo prior to their enrollment and throughout the entire study may be considered eligible; subjects will be excluded if they are taking physician prescribed vitamin and/or mineral supplements
• Taking >6 prescription or OTC drugs on a chronic basis

Length of Study
18 weeks, including 14 weeks of multivitamin/mineral supplementation

Number of Visits
1 screening visit; 3 study visits for collection of blood and urine samples, as well as collecting and dietary and clinical information (i.e., blood pressure, weight, etc.).

Residency
None

Can I work?
Yes, but if subjects employed by Tufts University qualify to participate in the study, they cannot participate as volunteers during hours in which they are being compensated by Tufts University for their regular work. This includes the use of vacation, personal days and sick time.

Study diet
Subjects must maintain their regular diet throughout the 16 week trial.
Participants must be willing to stop all dietary supplements for the duration of the study.

Stipend
$25 for screening, and up to $500, including the screening stipend, for participants who qualify and complete the entire study

NOTES:
Length of study

Total length of the study including resident stays and nonresident visits.
This does not mean you will be testing the entire time.
Residency

The length of time volunteers are required to stay overnight at the HNRCA. Residents have their own private room, bathroom, television, VCR, and phone during their stay.
Payment

The amount of reimbursement for travel and inconvenience.
Number of visits

Total number of nonresident visits.
Study diet

Indicates meals which will be provided by the HNRCA
Can I work?

Indicates if you will be able to work and if so, when.

For more information about this study, please call Volunteer Services at 1-800-738-7555.

We appreciate your interest in our program and we hope to work with you in the future.

Thank you,
The Recruitment Office
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University