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

May 3, 2018 updated by: Berdine Martin, Purdue University

The Effect of Particle Size of Calcium Carbonate and Vitamin D on Calcium and Bone Parameters in Adolescent Girls

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • West Lafayette, Indiana, United States, 47906
        • Purdue University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Small Particle Size Calcium Carbonate
Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Dietary supplement: Small Particle Size Calcium Carbonate Supplement
Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
Active Comparator: Large Particle Size Calcium Carbonate
Subjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Dietary supplement: Large Particle Size Calcium Carbonate Supplement
Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.
Placebo Comparator: Calcium Placebo
Subjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements.
Dietary supplement: Calcium Placebo

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

Given twice daily.
Active Comparator: No Vitamin D supplement
Subjects are given calcium carbonate supplement once daily (325 mg/d from supplement).
Dietary supplement: Small Particle Size Calcium Carbonate Supplement
Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
Experimental: Vitamin D supplement
Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.
Dietary supplement: Small Particle Size Calcium Carbonate Supplement
Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
Dietary supplement: Vitamin D
Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium Balance
Time Frame: weeks 2,3 + 5,6
Total calcium(Ca) retention will be calculated - Ca retention/d = Ca intake/d - Ca excretion/d (urine + feces)
weeks 2,3 + 5,6
Calcium Absorption
Time Frame: Day 15, 30
Day 15, 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum parathyroid hormone suppression
Time Frame: Day 19, 40
Serum PTH will be measured by a 2-site immunoassay
Day 19, 40
Serum 25-hydroxyvitamin D
Time Frame: Day 1, 20, 2, 41
Serum 25-hydroxyvitamin Dwill be measured by LCMS
Day 1, 20, 2, 41
Urinary Calcium
Time Frame: Weeks 2,3 + 5,6
Ca content of all 24 h urine collections will be measured by Atomic Absorption Spectrophotometry
Weeks 2,3 + 5,6
Fecal Calcium
Time Frame: Weeks 2,3 + 5,6
Ca content of all fecal collections will be measured by Atomic Absorption Spectrophotometry
Weeks 2,3 + 5,6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0609004386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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