Calcium Metabolism in Asian Adolescents - Full Text View

Sponsors and Collaborators:	Purdue University National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	Purdue University
ClinicalTrials.gov Identifier:	NCT00591708

Purpose

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.

Condition	Intervention
Bone Mineralization Adolescent Development	Dietary Supplement: Beverage containing calcium citrate malate Dietary Supplement: Beverage fortified with calcium citrate malate

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Crossover Assignment, Efficacy Study
Official Title:	Calcium Metabolism in Asian Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dietary Supplements Diets

Drug Information available for: Citric acid Calcium gluconate Calcium citrate Sodium Citrate Malic acid

U.S. FDA Resources

Further study details as provided by Purdue University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	34
Study Start Date:	July 2004
Study Completion Date:	August 2005
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: 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.	Dietary Supplement: Beverage fortified with calcium citrate malate Beverages containing a higher amount of calcium (500-1300 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.
A: 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.	Dietary Supplement: Beverage containing calcium citrate malate Beverages containing a lower amount of calcium (0-400 mg/d) will be supplemented to a basal diet containing 600 mg/d Ca. The controlled diet will be consumed for 21 consecutive days.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	11 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591708

Locations

United States, Indiana
Department of Foods and Nutrition, Purdue University
West Lafayette, Indiana, United States, 47907-2059

Sponsors and Collaborators

Purdue University

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

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

More Information

No publications provided

Responsible Party:	Department of Foods and Nutrition, Purdue University ( Connie Weaver/Professor and Head of Department )
Study ID Numbers:	AR40553, R01 AR040553
Study First Received:	December 26, 2007
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00591708 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Purdue University:

calcium
bone
bone density
adolescence

Study placed in the following topic categories:

Calcium, Dietary
Anticoagulants
Citric Acid

Citrate
Bone Density Conservation Agents
Chelating Agents

Additional relevant MeSH terms:

Calcium, Dietary
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Physiological Effects of Drugs
Citric Acid
Bone Density Conservation Agents
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009