Clinical trial NCT01005381: Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls
Official title: The Effect of Particle Size of Calcium Carbonate and Vitamin D on Calcium and Bone Parameters in Adolescent Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Calcium
Vitamin D
Particle Size
Adolescents
Bone
Osteoporosis
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 55
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Calcium Balance
timeFrame: weeks 2,3 + 5,6
measure: Calcium Absorption
timeFrame: Day 15, 30
Secondary outcomes:
measure: Serum parathyroid hormone suppression
timeFrame: Day 19, 40
measure: Serum 25-hydroxyvitamin D
timeFrame: Day 1, 20, 2, 41
measure: Urinary Calcium
timeFrame: Weeks 2,3 + 5,6
measure: Fecal Calcium
timeFrame: Weeks 2,3 + 5,6
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Connie M Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park CY, Hill KM, Elble AE, Martin BR, DiMeglio LA, Peacock M, McCabe GP, Weaver CM. Daily supplementation with 25 mug cholecalciferol does not increase calcium absorption or skeletal retention in adolescent girls with low serum 25-hydroxyvitamin D. J Nutr. 2010 Dec;140(12):2139-44. doi: 10.3945/jn.110.124891. Epub 2010 Oct 20.