Calcium Metabolism in Mexican American Adolescents

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Purdue University
ClinicalTrials.gov Identifier:
NCT01277185
First received: January 12, 2011
Last updated: January 13, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Osteoporosis
Dietary Supplement: Low Calcium Diet
Dietary Supplement: High Calcium Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Calcium Metabolism in Mexican American Adolescents

Resource links provided by NLM:


Further study details as provided by Purdue University:

Primary Outcome Measures:
  • Calcium Absorption and Retention [ Time Frame: June 2010-July 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone Density [ Time Frame: June 2010-July 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low Calcium Diet (600-1200 mg/d) Dietary Supplement: Low Calcium Diet
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.
Active Comparator: High Calcium Diet (1100-2300mg/d) Dietary Supplement: High Calcium Diet
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277185

Locations
United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Investigators
Principal Investigator: Connie Weaver, PhD Purdue University
Study Director: Berdine Martin, PhD Purdue University
  More Information

No publications provided by Purdue University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Berdine Martin, PhD, Project Director, Purdue University Department of Foods and Nutrition
ClinicalTrials.gov Identifier: NCT01277185     History of Changes
Other Study ID Numbers: Camp Calcium 11, 1R01HD061908-01A2
Study First Received: January 12, 2011
Last Updated: January 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Purdue University:
calcium
healthy
Mexican-American adolescents
camp
girls
boys
bone

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014