NCT01005381

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Purdue University · Academic / Other
• Sex: Female
• Age: 12 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoporosis

Interventions

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

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2009-11-02
• Last updated: 2018-05-09

Locations

1 site across 1 country: United States