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OpenTrials
Completed

NCT Number: NCT00591708

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.

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Key information

Conditions

Bone Mineralization Adolescent Development

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Foods and Nutrition, Purdue University

West Lafayette, Indiana, 47907-2059, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beverage containing calcium citrate malate

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.

Beverage fortified with calcium citrate malate

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

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

Registry information

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jan 11, 2008
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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