Clinical trial NCT02457247
Conditions: Calcium and Vitamin D Deficiencies
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2015-06-01; Completion date: 2015-08-01
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
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 sequences, 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-center 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.

Arms: arm 1: Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) \[A\], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) \[B\], chewable tablets, orally, twice, daily, on Days 15 through 28. arm 2: Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28. arm 3: Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) \[C\], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) \[D\], chewable tablets, orally, once, daily, on Days 15 through 28. arm 4: Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
Interventions: intervention 1: Calcichew D3 intervention 2: Adcal-D3 intervention 3: Kalcipos-D
Intervention descriptions: intervention 1: Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) intervention 2: Adcal-D3 (Calcium 600mg/400 IU Vitamin D3) intervention 3: Kalcipos-D (Calcium 500mg/800 IU Vitamin D3)

Protocol documents: