Calcium Metabolism in Mexican American Adolescents

Osteoporosis Clinical Trial

Official title:

Calcium Metabolism in Mexican American Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277185
• Other study ID #: Camp Calcium 11
• Secondary ID: 1R01HD061908-01A
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: August 2010

Study information

• Verified date: May 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium Absorption and Retention		June 2010-July 2010
Secondary	Bone Density		June 2010-July 2010