Effect of Calcium Supplement Particle Size and Vitamin D Supplement on Calcium Retention in Adolescent Girls
NCT ID: NCT01005381
Last Updated: 2018-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2007-06-30
2007-07-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Small Particle Size Calcium Carbonate
Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from 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.
Large Particle Size Calcium Carbonate
Subjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Large Particle Size Calcium Carbonate Supplement
Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.
Calcium Placebo
Subjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements.
Calcium Placebo
Placebo tablets identical to the large and small particle size calcium carbonate tablets.
Given twice daily.
No Vitamin D supplement
Subjects are given calcium carbonate supplement once daily (325 mg/d from 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.
Vitamin D supplement
Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D 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.
Vitamin D
Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.
Interventions
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Small Particle Size Calcium Carbonate Supplement
Small Particle Size Calcium Carbonate - tablet, 325 mg/tablet. Given once or twice daily depending on study arm.
Large Particle Size Calcium Carbonate Supplement
Large Particle Size Calcium Carbonate Supplement - tablet, 325 mg/tablet. Given twice daily.
Vitamin D
Vitamin D - capsule, cholecalciferol, 1000 IU/tablet. Given once daily.
Calcium Placebo
Placebo tablets identical to the large and small particle size calcium carbonate tablets.
Given twice daily.
Eligibility Criteria
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Inclusion Criteria
* Generally Healthy
Exclusion Criteria
* Malabsorptive disorders, bone, liver, or kidney disease that may affect calcium metabolism
* Oral contraceptive use
* Pregnancy
12 Years
14 Years
FEMALE
Yes
Sponsors
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Purdue University
OTHER
Responsible Party
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Berdine Martin
Research Scientist, Nutrition Science
Principal Investigators
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Connie M Weaver, PhD
Role: PRINCIPAL_INVESTIGATOR
Purdue University
Locations
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Purdue University
West Lafayette, Indiana, United States
Countries
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References
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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.
Other Identifiers
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0609004386
Identifier Type: -
Identifier Source: org_study_id
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