| December 26, 2007 |
| January 10, 2008 |
| July 2004 |
| August 2005 (final data collection date for primary outcome measure) |
| Calcium retention (mg/d) [ Time Frame: Metabolic balance will be determined over a two week period on a controlled diet after equilibration for one week on the same diet. ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00591708 on ClinicalTrials.gov Archive Site |
| Serial serum biochemistry profiles (PTH, 1,25 dihydroxy-vitamin D, calcium) [ Time Frame: Six serial measurements in 10 hours after ingestion of a calcium load representing one third of the daily consumption ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Calcium Metabolism in Asian Adolescents |
| Calcium Metabolism in Asian Adolescents |
Maximizing calcium retention by the skeleton within the genetic potential is a key strategy to prevent osteoporosis. It has been shown that calcium retention varies between blacks and whites and between gender within race. This study is designed to study the relationship between calcium intakes and calcium retention in Asian adolescent girls and boys. It is hypothesized that calcium intakes which maximize calcium retention will be lower in Asians than for whites studies under the same conditions. In addition it is thought that the differences between races in the physiological mechanisms involved in calcium metabolism will result in a lower calcium intake required to observe a plateau in calcium retention. This is turn could be translated into lower calcium requirements in Asians relative to Caucasians for achieving optimal peak bone mass. |
Adolescent Asian boys and girls will consume a controlled diet for two three-week periods. The basal diet will contain 600 mg/d calcium and will be supplemented with beverages fortified with calcium citrate malate to achieve a range of intakes from 600-2100 mg Ca/d. Each participant will be studied on one of four combinations of a lower and a higher calcium intake within that range in a cross-over design. |
| |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Crossover Assignment, Efficacy Study |
- Bone Mineralization
- Adolescent Development
|
- Dietary Supplement: Beverage containing calcium citrate malate
- Dietary Supplement: Beverage fortified with calcium citrate malate
|
- Experimental: Supplementation of a higher level of calcium (500-1300 mg/d) via calcium fortified beverages to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected.
- Experimental: Supplementation of a lower level of calcium (0-400 mg/d) via calcium fortified beverages to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected.
|
| |
| |
| Completed |
| 34 |
| August 2005 |
| August 2005 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- healthy teens of Asian descent
Exclusion Criteria:
- malabsorptive disorders
- anemia
- smoking, illegal drugs
- oral contraceptives
- pregnancy
- drugs that influence calcium metabolism
- body weight for height greater than 85 percentile
|
| Both |
| 11 Years to 15 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00591708 |
| Connie Weaver/Professor and Head of Department, Department of Foods and Nutrition, Purdue University |
| AR40553, R01 AR040553 |
| Purdue University |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| Principal Investigator: |
Connie Weaver, PhD |
Department of Foods and Nutrition, Purdue University |
|
| Study Director: |
Berdine R Martin, PhD |
Department of Foods and Nutrition, Purdue University |
|
|
| Purdue University |
| December 2007 |
