Calcium Metabolism in Asian Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bone Mineralization Adolescent Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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B

Supplementation of a higher level of calcium (500-1300 mg/d) via calcium fortified beverages (calcium citrate malate) to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected.

Group Type EXPERIMENTAL

Beverage fortified with calcium citrate malate

Intervention Type DIETARY_SUPPLEMENT

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

Supplementation of a lower level of calcium (0-400 mg/d) via calcium fortified beverages (calcium citrate malate) to a basal diet of 600 mg/d for 21 consecutive days. All excreta will be collected.

Group Type EXPERIMENTAL

Beverage containing calcium citrate malate

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No