Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls

NCT ID: NCT01005381

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study has two research arms:

The purpose of the 1st is to determine if a smaller particle size calcium carbonate supplement (than that which is now commercially available) improves calcium absorption and retention in adolescents girls.

The purpose of the 2nd is to determine if vitamin D supplementation improves calcium absorption and retention in adolescents girls.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

An important strategy to reducing the risk for osteoporosis and fracture in later life is to optimize the development of peak bone mass during adolescence. Because calcium is the main mineral component of bone, maximizing calcium absorption and retention during adolescence is important to maximize peak bone mass.

Our two research arms address two different mechanisms by which calcium absorption and retention may be increased:

1. We hypothesize that a smaller particle size calcium carbonate supplement (than that which is now commercially available) may be better absorbed and lead to higher calcium retention in adolescents.
2. We hypothesize that vitamin D supplementation will increased calcium absorption and retention in adolescents.

Subjects will be assigned to one of the two research arms.

1)Small and large particle size calcium supplements or placebo or 2) calcium supplements with or without vitamin D supplements will be given to subjects during two 3-week study periods in which subjects live on-site.

Calcium absorption will be measured by parathyroid hormone suppression after a calcium load and by stable calcium isotope in some subjects.

Calcium retention will be measured by calcium intake minus calcium excretion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Small Particle Size Calcium Carbonate

Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).

Group Type EXPERIMENTAL

Small Particle Size Calcium Carbonate Supplement

Intervention Type DIETARY_SUPPLEMENT

Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.

Large Particle Size Calcium Carbonate

Subjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).

Group Type ACTIVE_COMPARATOR

Large Particle Size Calcium Carbonate Supplement

Intervention Type DIETARY_SUPPLEMENT

Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.

Calcium Placebo

Subjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements.

Group Type PLACEBO_COMPARATOR

Calcium Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo tablets identical to the large and small particle size calcium carbonate tablets.

Given twice daily.

No Vitamin D supplement

Subjects are given calcium carbonate supplement once daily (325 mg/d from supplement).

Group Type ACTIVE_COMPARATOR

Small Particle Size Calcium Carbonate Supplement

Intervention Type DIETARY_SUPPLEMENT

Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.

Vitamin D supplement

Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.

Group Type EXPERIMENTAL

Small Particle Size Calcium Carbonate Supplement

Intervention Type DIETARY_SUPPLEMENT

Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Small Particle Size Calcium Carbonate Supplement

Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.

Intervention Type DIETARY_SUPPLEMENT

Large Particle Size Calcium Carbonate Supplement

Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.

Intervention Type DIETARY_SUPPLEMENT

Calcium Placebo

Placebo tablets identical to the large and small particle size calcium carbonate tablets.

Given twice daily.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 12-14 year old girls
* Generally Healthy

Exclusion Criteria

* History of alcohol, smoking, or non-prescription drug use
* Malabsorptive disorders, bone, liver, or kidney disease that may affect calcium metabolism
* Oral contraceptive use
* Pregnancy
Minimum Eligible Age

12 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Purdue University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Berdine Martin

Research Scientist, Nutrition Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Connie M Weaver, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Purdue University

West Lafayette, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Park CY, Hill KM, Elble AE, Martin BR, DiMeglio LA, Peacock M, McCabe GP, Weaver CM. Daily supplementation with 25 mug cholecalciferol does not increase calcium absorption or skeletal retention in adolescent girls with low serum 25-hydroxyvitamin D. J Nutr. 2010 Dec;140(12):2139-44. doi: 10.3945/jn.110.124891. Epub 2010 Oct 20.

Reference Type DERIVED
PMID: 20962148 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0609004386

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.