Purdue University
West Lafayette, Indiana, 47906, United States
NCT Number: NCT01005381
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.
Looking for future studies?
Notify Me12 year–14 year
Female
Interventional
Not applicable
West Lafayette, Indiana, 47906, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Placebo tablets identical to the large and small particle size calcium carbonate tablets.
Given twice daily.
Time frame: weeks 2,3 + 5,6
Total calcium(Ca) retention will be calculated - Ca retention/d = Ca intake/d - Ca excretion/d (urine + feces)
Time frame: Day 15, 30
Time frame: Day 19, 40
Serum PTH will be measured by a 2-site immunoassay
Time frame: Day 1, 20, 2, 41
Serum 25-hydroxyvitamin Dwill be measured by LCMS
Time frame: Weeks 2,3 + 5,6
Ca content of all 24 h urine collections will be measured by Atomic Absorption Spectrophotometry
Time frame: Weeks 2,3 + 5,6
Ca content of all fecal collections will be measured by Atomic Absorption Spectrophotometry
Purdue University
Other
The Effect of Particle Size of Calcium Carbonate and Vitamin D on Calcium and Bone Parameters in Adolescent Girls
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07725081
Attitudes, Behavior
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT05541432
Behavior, Bone Diseases
Waterloo, Ontario, Canada
View Trial DetailsNCT03924414
Atypical Parkinsonism, Autonomic Nervous System Diseases
Scottsdale, Arizona, United States
View Trial DetailsNCT02924545
Bone Diseases, Bone Diseases, Metabolic
Nîmes, France
View Trial Details