Calcium and Vitamin D Deficiencies Clinical Trial
Official title:
A Randomized, Open-Label, 2-Way Cross-Over, Phase 4 Study to Evaluate Subject Preference and Acceptability of a New Formulation of Calcichew D3 in Adult Patients Eligible for Calcium and Vitamin D Supplementation
The purpose of this study is to compare the preference of Calcichew D3 500/400 (containing 500 mg calcium and 400 IU of vitamin D) with Adcal-D3 600/400 (containing 600 mg of calcium and 400 IU of vitamin D) in Test Group 1, and to compare Calcichew D3 500/800 (containing 500 mg calcium and 800 IU vitamin D) with Kalcipos-D 500/800 (containing 500 mg of calcium and 800 IU of vitamin D) in Test Group 2.
The drug being tested in this study is called Calcichew D3 new formulations: Calcichew D3
500/400 and Calcichew D3 500/800. Calcichew D3 500/400 and Calcichew D3 500/800 are being
tested to treat or prevent calcium or vitamin D deficiencies. Calcichew D3 500/400 will be
compared to Adcal-D3 600/400 as prescribed in clinical practice and Calcichew D3 500/800
will be compared to Kalcipos-D 500/800 as prescribed in clinical practice.
This Crossover study will enroll approximately 276 patients equally divided between the two
test groups (138 patients each). Within each test group, participants will be randomly
assigned (by chance, like flipping a coin) to one of two treatment sequnces, as described
below.
Test Group 1:
- Calcichew D3 500/400 (containing 500 mg calcium and 400 IU of vitamin D) chewable
tablet
- Adcal-D3 600/400 (containing 600 mg of calcium and 400 IU of vitamin D) chewable tablet
Test Group 2:
- Calcichew D3 500/800 (containing 500 mg calcium and 800 IU vitamin D) chewable tablets
- Kalcipos-D 500/800 (containing 500 mg of calcium and 800 IU of vitamin D) chewable
tablets
Participants in Test Group 1 will take either Calcichew D3 500/400 or Adcal-D3 600/400 for
14 days and then will crossover to take either Calcichew D3 500/400 or Adcal-D3 600/400
treatment for 14 days. Participants in Test Group 2 will take either Calcichew D3 500/800 or
Kalcipos-D 600/400 for 14 days and then will crossover to take either Calcichew D3 500/800
or Kalcipos-D treatment for 14 days.
This multi-centre trial will be conducted In the United Kingdom and Germany. The overall
time to participate in this study is 28 days. Participants will make multiple visits to the
clinic including a final visit assessment at Day 28.
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Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment