At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 55 enrolled
Drug / intervention
Calcium 500 mg and Vitamin D3 800 IU +1 moredrug
Likely dose
Calcium 500 mg and Vitamin D3 800 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two Period, One-sequence Open-label Study of a Newly Developed Calcium Carbonate-vitamin D3 Chewable Tablet Formulation (Calcium 500 mg and Vitamin D3 800) Dosed for Three Days to Investigate the Effect on Urine Calcium and Serum Parathyroid Hormone (PTH) as Measurements of Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men Compared to Baseline.
In Brief
A Phase 1 clinical trial evaluating Calcium 500 mg and Vitamin D3 800 IU and Low calcium meals for Calcium Deficiency and Vitamin D Deficiency. Completed, enrolled 55 participants across 1 site.
Detailed Summary
The purpose of this study is to demonstrate that the intestinal absorption of calcium from a newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to baseline.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCalcium Deficiency, Vitamin D Deficiency
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedJul 2012
Primary CompletionAug 2012
TodayJul 2026
First PostedJul 12, 2012
Enrollment StartJul 1, 2012
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.0 years ago
Interventions
Calcium 500 mg and Vitamin D3 800 IUdrug
Calcium 500 mg and Vitamin D3 800 IU chewable tablets
Low calcium mealsother
A normal Western European diet with reduced calcium content (400 mg per day).