NCT01277185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

January 12, 2011

Last Update Submit

May 3, 2018

Conditions

Osteoporosis

Keywords

calciumhealthyMexican-American adolescentscampgirlsboysbone

Outcome Measures

Primary Outcomes (1)

  • Calcium Absorption and Retention

    June 2010-July 2010

Secondary Outcomes (1)

  • Bone Density

    June 2010-July 2010

Study Arms (2)

Low Calcium Diet (600-1200 mg/d)

ACTIVE COMPARATOR
Dietary Supplement: Low Calcium Diet

High Calcium Diet (1100-2300mg/d)

ACTIVE COMPARATOR
Dietary Supplement: High Calcium Diet

Interventions

Low Calcium DietDIETARY_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.

Low Calcium Diet (600-1200 mg/d)
High Calcium DietDIETARY_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.

High Calcium Diet (1100-2300mg/d)

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

    PMID: 24872223DERIVED

MeSH Terms

Conditions

OsteoporosisMuscle Cramp

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Connie Weaver, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

  • Berdine Martin, PhD

    Purdue University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist, Nutrition Science

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 14, 2011

Study Start

April 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

US(1)