Phase 4
Completed N=276
Calcichew D3 Preference Study in Participants Eligible for Calcium and Vitamin D Supplementation.
Calcium and Vitamin D Deficiencies
Source: ClinicalTrials.gov NCT02457247 ↗
Enrolled (actual)
276
Serious AEs
0.2%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants With a Preference for Each Treatment Within Each Test Group — 67.2; 72.3; 61.8; 52.9 percentage of participants
◆ Published Evidence
Emerging
3citations · ~0 / year
Phase IV randomized preference study in patients eligible for calcium and vitamin D supplementation.
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.
Linked Publications
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Phase IV randomized preference study in patients eligible for calcium and vitamin D supplementation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Preference for Each Treatment Within Each Test Group |
67.2; 72.3; 61.8; 52.9; 69.8; 57.2 | — |
| SECONDARY Product Acceptability After Each 14 Day Dosing Period Within Each Test Group |
19.2; 24.6; 28.4; 27.0; 23.2; 41.1 | — |
| SECONDARY Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group |
14.8; 9.6; 5.1; 4.3 | — |
Eligibility Criteria
Inclusion Criteria
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- Signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- 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.
- Eligible participants will either be:
- Aged 65 years or older requiring calcium and vitamin D supplementation for the prevention or treatment of deficiencies, or
- 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.
- Is male or female.
- 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
- 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.
- Has received any investigational compound within 30 days prior to Screening.
- 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.
- 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).
- 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.
- Has a history of hypersensitivity or allergies to the active substances or to any of the excipients in the investigational products.
- Has a history of known fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
- 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.
Data sourced from ClinicalTrials.gov (NCT02457247) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.