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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
55
Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.
Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.
Purdue University
West Lafayette, Indiana, United States
Calcium Balance
Total calcium(Ca) retention will be calculated - Ca retention/d = Ca intake/d - Ca excretion/d (urine + feces)
Time frame: weeks 2,3 + 5,6
Calcium Absorption
Time frame: Day 15, 30
Serum parathyroid hormone suppression
Serum PTH will be measured by a 2-site immunoassay
Time frame: Day 19, 40
Serum 25-hydroxyvitamin D
Serum 25-hydroxyvitamin Dwill be measured by LCMS
Time frame: Day 1, 20, 2, 41
Urinary Calcium
Ca content of all 24 h urine collections will be measured by Atomic Absorption Spectrophotometry
Time frame: Weeks 2,3 + 5,6
Fecal Calcium
Ca content of all fecal collections will be measured by Atomic Absorption Spectrophotometry
Time frame: Weeks 2,3 + 5,6
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Placebo tablets identical to the large and small particle size calcium carbonate tablets. Given twice daily.