Comparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills

Laval University

Status and phase: Completed; Phase 4

Conditions: Vitamin D Deficiency

Treatments: Drug: Vitamin D pill supplementation; Drug: Vitamin D chewable tablet supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02158598

B14-03-1896

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 3 patient groups

wash-out

No Intervention group

Description:

2 months

Vitamin D chewable tablet supplementation

Experimental group

Description:

A chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months.

Treatment:

Drug: Vitamin D chewable tablet supplementation

Vitamin D pill supplementation

Experimental group

Description:

A vitamin D pill containing 1000 IU to be taken once a day for 2 months.

Treatment:

Drug: Vitamin D pill supplementation