Calcium Metabolism in Asian Adolescents

May 3, 2018 updated by: Berdine Martin, Purdue University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Metabolic balance will be determined over a two week period on a controlled diet after equilibration for one week on the same diet.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Six serial measurements in 10 hours after ingestion of a calcium load representing one third of the daily consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR40553
  • R01AR040553 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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