Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030238
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2002-02-12
Brief Title:
Supplemental Calcium in Overweight People
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Supplemental Calcium in Overweight Out-Patients
Status:
COMPLETED
Status Verified Date:
2014-10-28
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgday 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
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 mgday 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
Detailed Description:
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 992 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 mgday of supplementary calcium vs placebo in adults with a BMI greater than or equal to 25 kgm2 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
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 mgday of supplementary calcium vs placebo in adults with a BMI greater than or equal to 25 kgm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CH-0100 | None | None | None |