Calcium Metabolism in Asian Adolescents

Adolescent Development Clinical Trial

Official title:

Calcium Metabolism in Asian Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591708
• Other study ID #: AR40553
• Secondary ID: R01AR040553
• Status: Completed
• Phase: N/A
• Start date: July 2004
• Est. completion date: August 2005

Study information

• Verified date: May 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Development
• Bone Mineralization

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Department of Foods and Nutrition, Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium retention (mg/d)		Metabolic balance will be determined over a two week period on a controlled diet after equilibration for one week on the same diet.
Secondary	Serial serum biochemistry profiles (PTH, 1,25 dihydroxy-vitamin D, calcium)		Six serial measurements in 10 hours after ingestion of a calcium load representing one third of the daily consumption