Overview

This trial is active, not recruiting.

Condition vitamin d deficiency
Treatments vitamin d chewable tablet supplementation, vitamin d pill supplementation
Phase phase 4
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Collaborator Khlôros Technology
Start date June 2014
End date December 2016
Trial size 38 participants
Trial identifier NCT02158598, B14-03-1896

Summary

This is a 6-month cross-over trial of vitamin D supplementation in 38 healthy men and women aged 18 years and older. The primary aim is to compare the change in serum 25(OH)D concentration following vitamin D supplementation with chewable tablets versus pills. Secondary aims are to evaluate satisfaction and adherence to the vitamin D chewable tablet supplement. Questionnaires on physical activity, sunlight exposure and dairy product consumption will be administered to adjust for confounding factors. A questionnaire will be administered to assess satisfaction and pill count to evaluate adherence to treatment. This research intends to test the hypothesis that the vitamin D chewable tablet supplement is as effective as a traditional vitamin D pill supplement to increase serum 25(OH)D concentrations.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-equivalence study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
2 months
(Experimental)
A chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months.
vitamin d chewable tablet supplementation
(Experimental)
A vitamin D pill containing 1000 IU to be taken once a day for 2 months.
vitamin d pill supplementation

Primary Outcomes

Measure
Change in Serum 25(OH)D concentration
time frame: 0 and 2 months, 4 and 6 months

Secondary Outcomes

Measure
Satisfaction with the vitamin D chewable tablets and pills.
time frame: 0 and 2 months, 4 and 6 months
Adherence to the vitamin D chewable tablets and pills.
time frame: 0 and 2 months, 4 and 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Caucasian men and women; - Aged 18 years and older; - Having a serum 25(OH)D concentration of 75 nmol/L or less. Exclusion Criteria: - Regular consumption of a supplement containing > 400 IU/d of vitamin D over the last 2 months; - Intestinal malabsorption; - Cirrhosis; - Renal insufficiency (creatinine clearance <60 ml/min); - Hypercalcemia; - Pregnancy; - Breastfeeding; - Inability to provide informed consent.

Additional Information

Principal investigator Claudia Gagnon, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.