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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005381
• Other study ID #: 0609004386
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: July 2007

Study information

• Verified date: May 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• Large Particle Size Calcium Carbonate Supplement
Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.
• Vitamin D
Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.
• Calcium Placebo
Placebo tablets identical to the large and small particle size calcium carbonate tablets. Given twice daily.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calcium Balance	Total calcium(Ca) retention will be calculated - Ca retention/d = Ca intake/d - Ca excretion/d (urine + feces)	weeks 2,3 + 5,6
Primary	Calcium Absorption		Day 15, 30
Secondary	Serum parathyroid hormone suppression	Serum PTH will be measured by a 2-site immunoassay	Day 19, 40
Secondary	Serum 25-hydroxyvitamin D	Serum 25-hydroxyvitamin Dwill be measured by LCMS	Day 1, 20, 2, 41
Secondary	Urinary Calcium	Ca content of all 24 h urine collections will be measured by Atomic Absorption Spectrophotometry	Weeks 2,3 + 5,6
Secondary	Fecal Calcium	Ca content of all fecal collections will be measured by Atomic Absorption Spectrophotometry	Weeks 2,3 + 5,6