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Calcium Supplement
Small Particle Size Calcium Carbonate for Osteoporosis
N/A
Waitlist Available
Led By Connie M Weaver, PhD
Research Sponsored by Purdue University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 20, 2, 41
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.
Eligible Conditions
- Osteoporosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 20, 2, 41
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 20, 2, 41
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Calcium Balance
Secondary study objectives
Fecal Calcium
Serum 25-hydroxyvitamin D
Serum parathyroid hormone suppression
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Vitamin D supplementExperimental Treatment2 Interventions
Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.
Group II: Small Particle Size Calcium CarbonateExperimental Treatment1 Intervention
Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Group III: No Vitamin D supplementActive Control1 Intervention
Subjects are given calcium carbonate supplement once daily (325 mg/d from supplement).
Group IV: Large Particle Size Calcium CarbonateActive Control1 Intervention
Subjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
Group V: Calcium PlaceboPlacebo Group1 Intervention
Subjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Small Particle Size Calcium Carbonate Supplement
2007
N/A
~60
Vitamin D
2013
Completed Phase 4
~3670
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Who is running the clinical trial?
Purdue UniversityLead Sponsor
231 Previous Clinical Trials
71,113 Total Patients Enrolled
10 Trials studying Osteoporosis
292 Patients Enrolled for Osteoporosis
Connie M Weaver, PhDPrincipal InvestigatorPurdue University
6 Previous Clinical Trials
270 Total Patients Enrolled
4 Trials studying Osteoporosis
144 Patients Enrolled for Osteoporosis
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