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

Not Applicable

Completed

• Conditions: Osteoporosis
• Interventions: Dietary Supplement: Large Particle Size Calcium Carbonate Supplement; Dietary Supplement: Calcium Placebo; Dietary Supplement: Small Particle Size Calcium Carbonate Supplement; Dietary Supplement: Vitamin D

• Registration Number: NCT01005381
• Lead Sponsor: Purdue University

Brief Summary

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

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 Timeline

• Study Start: 2007-06
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Large Particle Size Calcium Carbonate	Large Particle Size Calcium Carbonate Supplement	Subjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Calcium Placebo	Calcium Placebo	Subjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements.
No Vitamin D supplement	Small Particle Size Calcium Carbonate Supplement	Subjects are given calcium carbonate supplement once daily (325 mg/d from supplement).
Vitamin D supplement	Vitamin D	Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.
Small Particle Size Calcium Carbonate	Small Particle Size Calcium Carbonate Supplement	Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Vitamin D supplement	Small Particle Size Calcium Carbonate Supplement	Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Purdue University; 🇺🇸 West Lafayette, Indiana, United States