Contact information
Type
Scientific
Primary contact
Prof Willem Lems
ORCID ID
Contact details
Vrije University Medical Centre
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
wf.lems@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CW-004-IN
Study information
Scientific title
Acronym
Study hypothesis
The aim of this trial was to assess the preference for a formulation based on the identification of some of the factors that may influence compliance with the intake of calcium plus vitamin D3 supplements.
Ethics approval
Ethics approval received from the Local Ethical Committee in February 2003.
Study design
Randomised, open, cross-over clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Osteoporosis
Intervention
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). The sachet of calcium plus vitamin D3 (Cad, Will-Pharma) contained 1250 mg of calcium carbonate (equivalent to 500 mg elemental calcium) and 440 IU of vitamin D3.
The patients received both trial medications for 14 days, which was considered adequate for a patient to become familiar with the formulation and to assess the preference and acceptability. The patients received either the chewable tablet for two weeks followed by the sachet for two weeks or vice versa.
Total duration follow-up: 28 weeks
Intervention type
Supplement
Phase
Not Specified
Drug names
Calcium, vitamin D3 supplementation
Primary outcome measures
To assess any preference between Calci-Chew D3 and Cad, measured at visit 3 (day 28).
Secondary outcome measures
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)
Overall trial start date
01/02/2003
Overall trial end date
30/11/2003
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/02/2003
Recruitment end date
30/11/2003
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije University Medical Centre
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
Nycomed (Denmark)
Sponsor details
Langebjerg 1
Roskilde
DK-4000
Denmark
Info@nycomed.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Nycomed (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary