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| Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Office of Dietary Supplements (ODS) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00030238 |
Purpose
This study will examine the health effects of calcium supplements in overweight adults. Overweight adults often eat a diet low in calcium. Some studies have found low calcium intake in people who have some of the medical problems often seen in overweight adults. This study will see if extra calcium improves the health of overweight adults.
Volunteers in general good health 18 years of age or older who are overweight (body mass index equal to or greater than 25 kilograms per square meter of body surface) may be eligible for this study. Women who are pregnant or breastfeeding may not participate. The study includes four visits, described below.
Visit 1
Volunteers will be screened for participation in the study with a medical history, physical examination, and blood and urine tests. At home, they will collect a 24-hour urine sample; fill out questionnaires to assess their average calcium intake; and record their food intake for 7 days. Those enrolled in the study will continue with the next 3 visits.
Visit 2
Participants will complete a physical activity questionnaire, have their food diary reviewed, and meet with a dietitian for nutritional counseling.
Triceps fold thickness and waist and hip circumferences will be measured three times. Body composition will be analyzed by a DEXA study. For this procedure, the subject lies on a flat table while a small dose of X-rays is passed through the body.
Participants will be randomly assigned to take either calcium carbonate (1500 mg/day) or placebo capsules twice a day by mouth for 2 years. (The placebo looks like the calcium capsules but contains no calcium.) They will receive a 6-month supply of study capsules during visit 2 and return to NIH every 6 months for the next supply. They will also be sent questionnaires by mail every 3 months to complete information about health problems and how often the study capsules are being taken.
Visits 3 and 4
Visit 3 is scheduled after participants have taken the study capsules for 1 year; visit 4 is scheduled after 2 years (the end of the study). At each of these visits, participants will have a DEXA scan, blood and urine tests, blood pressure measurements, and measurements of height, weight, waist and hip circumference. They will complete questionnaires about their medical history, side effects of the study medications, dietary calcium intake, and physical activity, and they will meet with one of the study investigators to talk about any concerns regarding the study. At the fourth visit, participants will answer some additional questions about their study participation and return the Diet History Questionnaire that was mailed to them before the visit.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Calcium supplement Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Supplemental Calcium in Overweight Out-Patients |
| Estimated Enrollment: | 570 |
| Study Start Date: | February 2002 |
| Arms | Assigned Interventions |
|---|---|
|
Active Treatment
Subjects take calcium twice daily with meals
|
Drug: Calcium supplement
Calcium Carbonate capsules prepared by NIH PDS
|
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Control
Subjects take placebo twice daily with meals.
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Drug: Placebo
Placebo capsules prepared by the NIH PDS to be identical to Calcium Carbonate capsules
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An estimated 97 million people in the United States are overweight or obese, and therefore have an increased risk for a number of other obesity-related co-morbid conditions (such as hypertension, dyslipidemia, and Type 2 Diabetes) as well as for all-cause mortality. The total cost attributable to obesity amounted to $99.2 billion in the US in 1995 and this figure, like the prevalence of increased body mass, is rising at an alarming rate. At the same time calcium intake in the US adult population is far below the RDA (recommended daily allowance) and much below the daily optimal calcium intake recommended by the 1994 NIH consensus conference. An analysis of the NHANES III database suggests a strong inverse association between relative risk of obesity and calcium intake. Further, both prospective studies in animal models, and retrospective analyses of human studies suggest calcium supplementation may play a role in minimizing yearly weight gain, and may possibly induce small weight losses.
In order to test the relationship between calcium intake and body weight, we propose to conduct a 2-year, randomized, double-blind, placebo-controlled trial of calcium supplementation (1500 mg/day of supplementary calcium vs. placebo) in adults with a BMI greater than or equal to 25 kg/m(2). We will study the effects of supplemental calcium on body weight, body composition, and obesity-related comorbid conditions, such as insulin sensitivity and lipids. The effects of such supplementation on blood pressure will also be systematically evaluated. A control group of untreated, healthy, adults will also be enrolled for comparisons to study subjects.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Volunteers will qualify if they meet the following criteria:
INCLUSION CRITERIA: (Normal Weight Subjects)
Volunteers will qualify if the meet the following criteria
Normal fasting serum Ca (2.05-2.55 mmol/L) and serum phosphorus levels (2.3-4.3 mg/dl).
EXCLUSION CRITERIA: (overweight subjects)
Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
EXCLUSION CRITERIA: (Normal Weight Subjects)
Volunteers will be excluded (and referred to non-experimental treatment programs as needed) for the following reasons:
Contacts and Locations
More Information
| Responsible Party: | National Institutes of Health ( Jack A. Yanovski, M.D./National Institute of Child Health and Human Development ) |
| Study ID Numbers: | 020100, 02-CH-0100 |
| Study First Received: | February 12, 2002 |
| Last Updated: | October 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00030238 History of Changes |
| Health Authority: | United States: Federal Government |
|
Body Fat Weight Gain Adult Hypertension |
Dietary Supplements Healthy Volunteer HIV Body Weight |
|
Calcium Supplement Obesity Acquired Immunodeficiency Syndrome Overweight Healthy Calcium Carbonate Weight Gain |
Body Weight Signs and Symptoms Calcium, Dietary HIV Infections Nutrition Disorders Overnutrition Hypertension |
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Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |