Overview
Comparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills
Status:
Completed
Completed
Trial end date:
2018-05-09
2018-05-09
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Centre Hospitalier Universitaire de Québec, CHU de Québec
CHU de Quebec-Universite LavalCollaborators:
Anne-Sophie Morisset
Khlôros TechnologyTreatments:
Ergocalciferols
Vitamin D
Vitamins
Criteria
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.