Calcichew D3 Preference Study in Participants Eligible for Calcium and Vitamin D Supplementation.
Condition: Calcium and Vitamin D Deficiencies
MeSH terms: Vitamin D Deficiency
Intervention: Calcichew D3; Adcal-D3; Kalcipos-D
Intervention description: 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)
Intervention MeSH terms: Calcium Carbonate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. Signs and dates a written, informed consent form and any required privacy
             authorization prior to the initiation of any study procedures.

          3. Is eligible for or currently receiving treatment with calcium and vitamin D supplement
             as determined by the treating clinician in accordance with local treatment guidelines.

          4. Eligible participants will either be:

               1. Aged 65 years or older requiring calcium and vitamin D supplementation for the
                  prevention or treatment of deficiencies, or

               2. Aged 18 years or older that require calcium and vitamin D as an adjunct to
                  specific osteoporosis treatment in participants at risk of calcium and vitamin D
                  deficiencies.

          5. Is male or female.

          6. A female participant of childbearing potential who is sexually active with a
             nonsterilized male partner agrees to use routinely adequate contraception from signing
             of informed consent throughout the duration of the study, and for 12 weeks after last
             dose of study medication.

        Exclusion Criteria:

          1. Has received Calcichew D3, Adcal-D3 (if the participant is in Test Group 1) or
             Kalcipos-D (if the participant is in Test Group 2) within the 6 months prior to the
             first dose of study medication.

          2. Has received any investigational compound within 30 days prior to Screening.

          3. Has a disease and/or condition resulting in hypercalcaemia and/or hypercalciuria and
             for which the study drugs are contraindicated e.g. Zollinger-Ellison syndrome,
             nephrolithiasis.

          4. Has any of the contraindications listed in the corresponding Summary of Product
             Characteristics (SPC) of the study drug that the participant may receive depending on
             the Test Group: Calcichew D3 or Adcal-D3 (if the participant is in Test Group 1);
             Calcichew D3 or Kalcipos-D (if the participant is in Test Group 2).

          5. Is an immediate family member, study site employee, or is in a dependant relationship
             with a study site employee who is involved in conduct of this study (eg, spouse,
             parent, child, sibling) or may consent under duress.

          6. Has a history of hypersensitivity or allergies to the active substances or to any of
             the excipients in the investigational products.

          7. Has a history of known fructose intolerance, glucose-galactose malabsorption or
             sucrase-isomaltase insufficiency.

          8. If female, the participant is pregnant or lactating or intending to become pregnant
             before, during, or within 12 weeks after participating in this study; or intending to
             donate ova during such time period.