Calcium Metabolism in Mexican American Adolescents
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Calcium Diet
High Calcium Diet
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring calcium, healthy, Mexican-American adolescents, camp, girls, boys, bone
Eligibility 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
Sites / Locations
- Purdue University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Low Calcium Diet (600-1200 mg/d)
High Calcium Diet (1100-2300mg/d)
Arm Description
Outcomes
Primary Outcome Measures
Calcium Absorption and Retention
Secondary Outcome Measures
Bone Density
Full Information
NCT ID
NCT01277185
First Posted
January 12, 2011
Last Updated
May 3, 2018
Sponsor
Purdue University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01277185
Brief Title
Calcium Metabolism in Mexican American Adolescents
Official Title
Calcium Metabolism in Mexican American Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Purdue University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
calcium, healthy, Mexican-American adolescents, camp, girls, boys, bone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Calcium Diet (600-1200 mg/d)
Arm Type
Active Comparator
Arm Title
High Calcium Diet (1100-2300mg/d)
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Low Calcium Diet
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
High Calcium Diet
Intervention Description
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 Outcome Measure Information:
Title
Calcium Absorption and Retention
Time Frame
June 2010-July 2010
Secondary Outcome Measure Information:
Title
Bone Density
Time Frame
June 2010-July 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Weaver, PhD
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berdine Martin, PhD
Organizational Affiliation
Purdue University
Official's Role
Study Director
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24872223
Citation
Palacios C, Martin BR, McCabe GP, McCabe L, Peacock M, Weaver CM. Dietary calcium requirements do not differ between Mexican-American boys and girls. J Nutr. 2014 Aug;144(8):1167-73. doi: 10.3945/jn.113.188318. Epub 2014 May 28.
Results Reference
derived
Learn more about this trial
Calcium Metabolism in Mexican American Adolescents
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