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NCT00030238 · ClinicalTrials.gov registry record · Phase 3
Supplemental Calcium in Overweight People
A Phase 3 study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
NCT00030238 is a Phase 3 study that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 540 participants.
The verdict
NCT00030238, a Phase 3 study, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
Study Summary
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 f
Interventions
- DRUG Placebo
- DRUG Calcium supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2002-02-06 |
| Est. Completion | 2007-12-14 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00030238
The ClinicalTrials.gov registry entry for NCT00030238 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00030238 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00030238 about?
NCT00030238 is a clinical study titled "Supplemental Calcium in Overweight People". 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 ...
What is the current status of trial NCT00030238?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2002-02-06. Estimated completion is 2007-12-14.
What interventions are being tested in trial NCT00030238?
The interventions under investigation include: Placebo (DRUG), Calcium supplement (DRUG).
Who is sponsoring clinical trial NCT00030238?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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