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

ISRCTN	ISRCTN18822358
DOI	https://doi.org/10.1186/ISRCTN18822358
Secondary identifying numbers	CW-004-IN

Submission date: 24/04/2008
Registration date: 09/06/2008
Last edited: 12/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Willem Lems
Scientific

Vrije University Medical Centre
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Email	wf.lems@vumc.nl

Study information

Study design	Randomised, open, cross-over clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Patient preference and acceptability of calcium plus vitamin D3 supplementation: a randomised, open, cross-over trial
Study objectives	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(s)	Ethics approval received from the Local Ethical Committee in February 2003.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/02/2003
Completion date	30/11/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200
Total final enrolment	102
Key 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
Key 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
Date of first enrolment	01/02/2003
Date of final enrolment	30/11/2003

Locations

Countries of recruitment

Netherlands

Study participating centre

Vrije University Medical Centre

Amsterdam
1081 HV
Netherlands

Sponsor information

Nycomed (Denmark)
Industry

Langebjerg 1
Roskilde
DK-4000
Denmark

Email	Info@nycomed.com
Website	http://www.nycomed.com/en/menu/
"ROR"	https://ror.org/03bsswy66

Funders

Funder type

Industry

Nycomed (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2010	30/12/2020	Yes	No

Editorial Notes

12/04/2021: Internal review.
30/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.