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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3)
Adcal-D3 (Calcium 600mg/400 IU Vitamin D3)
Kalcipos-D (Calcium 500mg/800 IU Vitamin D3)
Unnamed facility
Berlin, Germany
Unnamed facility
Bochum, Germany
Unnamed facility
Frankfurt, Germany
Unnamed facility
Leipzig, Germany
Percentage of Participants With a Preference for Each Treatment Within Each Test Group
Preference was assessed by a 3 box questionnaire. Participants checked off one of the boxes: I prefer the first product that was tested, I prefer the second product that was tested or I have no preference. Test Group 1 (United Kingdom): Calcichew D3 is 500/400 and the comparator is Adcal-D3. Test Group 2 (Germany): Calcichew D3 is 500/800 and the comparator is Kalcipos-D.
Time frame: Day 28
Product Acceptability After Each 14 Day Dosing Period Within Each Test Group
Product acceptability was assessed by a 6 item questionnaire evaluating the characteristics of the product: gritty, chalky, sweet, ease of chew, ease of swallow and sticky. Using a 100 mm visual analog scale (VAS) the participant put a vertical line through each horizontal line that best describes their level of agreement with each item using a 0 to 100 scale where: 0=far left of the line (best) to 100= far right of the line (worst). Linear mixed model was used for analysis with treatment and period as fixed effects and participants as a random effect.
Time frame: Day 14 and Day 28
Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: Day 1 to Day 28
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Unnamed facility
Reading, Berkshire, United Kingdom
Unnamed facility
Birmingham, United Kingdom
Unnamed facility
Chorley, United Kingdom
Unnamed facility
Liverpool, United Kingdom
Unnamed facility
Manchester, United Kingdom