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Completed

NCT Number: NCT01277185

Calcium Metabolism in Mexican American Adolescents

The purpose of this study is to identify calcium metabolism characteristics in Mexican American adolescents. The investigators predict that calcium requirements to maximize bone health in this population will be lower than for white youth but higher than their current intakes.

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Key information

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue University

West Lafayette, Indiana, 47907, United States

About this study

Previously significant racial and sex differences in calcium retention and kinetics in adolescents has been found. Other minority groups have increased calcium absorption efficiency at low calcium intakes in contrast to white adolescents. Since Hispanics and specifically Mexican Americans will soon comprise an increasing proportion of our population. We propose to identify calcium metabolism characteristics in this group. We predict that calcium requirements to maximize bone health in this population will be lower than for white youth but higher than their current intakes.

Thus the specific aims of this project include:

  • to establish calcium requirements
  • to establish the relationship between calcium intake and calcium absorption
  • to identify the major physiological parameters(kidney, intestine, bone) that contribute to calcium retention in Mexican-American adolescents

During this two-phase metabolic camp participants will consume either a higher calcium diet(1100-2300mg/d) or a lower calcium diet (600-1200mg/d) during the first 3-week phase and switch to the opposite regime during the second 3-week phase, with a 2-week washout period in between. Subjects will collect all excreta during both phases. Calcium absorption, height, weight, and bone density will evaluated throughout the 6-week period of the study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Normal, healthy adolescents of Mexican American descent
  • Mexican American boys age 13-15
  • Mexican American girls age 12-14

Exclusion criteria

  • Malabsorptive disorders
  • Anemia
  • Smoking
  • History of medications known to affect calcium metabolism
  • Body weight outside 85-120% of ideal body weight for height
  • Regular consumption of illegal drugs
  • Contraceptive use
  • Pregnancy

Treatment and study plan

Low Calcium Diet

Dietary Supplement

The basal diet will contain 600 mg of Ca per day and constant sufficient amounts of all other nutrients. Additional Ca will be given unfortified beverages served three times per day. Teens will be randomized to a lower (600-1200 mg/d)level of calcium in the first camp followed by the opposite (higher calcium diet)regime in the second camp.

High Calcium Diet

Dietary Supplement

The basal diet will contain 600 mg of Ca per day and constant sufficient amounts of all other nutrients. Additional Ca will be given unfortified beverages served three times per day. Teens will be randomized to a higher (1100-2300mg/d)level of calcium in the first camp followed by the opposite (lower calcium diet)regime in the second camp.

Primary outcomes

  1. Calcium Absorption and Retention

    Time frame: June 2010-July 2010

Secondary outcomes

  1. Bone Density

    Time frame: June 2010-July 2010

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2011
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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