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

Purdue University

Status: Completed

Conditions: Osteoporosis

Treatments: Dietary Supplement: Calcium Placebo; Dietary Supplement: Small Particle Size Calcium Carbonate Supplement; Dietary Supplement: Large Particle Size Calcium Carbonate Supplement; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT01005381

0609004386

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: Female

Ages: 12 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

55 participants in 5 patient groups, including a placebo group

Small Particle Size Calcium Carbonate

Experimental group

Description:

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

Treatment:

Dietary Supplement: Small Particle Size Calcium Carbonate Supplement

Large Particle Size Calcium Carbonate

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Large Particle Size Calcium Carbonate Supplement

Calcium Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Calcium Placebo

No Vitamin D supplement

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Small Particle Size Calcium Carbonate Supplement

Vitamin D supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D

Dietary Supplement: Small Particle Size Calcium Carbonate Supplement