Calcium Metabolism in Mexican American Adolescents

NCT ID: NCT01277185

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Low Calcium Diet (600-1200 mg/d)

Group Type ACTIVE_COMPARATOR

Low Calcium Diet

Intervention Type 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 (1100-2300mg/d)

Group Type ACTIVE_COMPARATOR

High Calcium Diet

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Berdine Martin

Research Scientist, Nutrition Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Connie Weaver, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Berdine Martin, PhD

Role: STUDY_DIRECTOR

Purdue University

Locations

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Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24872223 (View on PubMed)

Other Identifiers

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1R01HD061908-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Camp Calcium 11

Identifier Type: -

Identifier Source: org_study_id

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