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Patient preference and acceptability of calcium plus vitamin D3 supplementation: a randomised, open, cross-over trial

Patient preference and acceptability of calcium plus vitamin D3 supplementation: a randomised, open, cross-over trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18822358
Enrollment
200
Registered
2008-06-09
Start date
2003-02-01
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis Musculoskeletal Diseases Osteoporosis without pathological fracture

Interventions

The Calci-Chew D3 chewable tablets (Nycomed, Denmark) contained 1250 mg of calcium carbonate (equivalent to 500 mg elemental calcium) and 400 IU of cholecalciferol (equivalent to 10 µg vitamin D3). Th

Sponsors

Nycomed (Denmark)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with osteoporosis who required calcium and vitamin D supplementation as part of their anti-osteoporotic therapy 2. Age range: greater than 18 years, gender: women and men

Exclusion criteria

Exclusion criteria: 1. Use of the trial medications during the past six months 2. Any condition for which the trial medications are contra-indicated, such as hypercalcaemia, hypercalciuria, Zollinger-Ellison syndrome, and nephrolithiasis 3. Use of drugs known to interact with the trial medications (e.g., digoxin, tetracycline, fluoroquinolones, bisphosphonates, iron, sodium fluoride, diuretics, phenytoin, barbiturates, corticosteroids, levothyroxine, ion exchange resins, laxatives) 4. Planned surgery during the four-week study period 5. Pregnant, possibly pregnant, or breastfeeding women

Design outcomes

Primary

MeasureTime frame
To assess any preference between Calci-Chew D3 and Cad, measured at visit 3 (day 28).

Secondary

MeasureTime frame
1. To compare acceptability of the formulations using an 11-point rating scale, measured at visit 2 (day 14) and visit 3 (day 28) 2. To record tolerability and adverse events, measured at visit 2 (day 14) and visit 3 (day 28)

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026