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

Phase 4

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: Vitamin D pill supplementation; Drug: Vitamin D chewable tablet supplementation

• Registration Number: NCT02158598
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-02
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-09
• Primary Completion: 2017-12
• Study Completion: 2018-05-09
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin D pill supplementation	Vitamin D pill supplementation	A vitamin D pill containing 1000 IU to be taken once a day for 2 months.
Vitamin D chewable tablet supplementation	Vitamin D chewable tablet supplementation	A chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months.

Primary Outcome Measures

Name	Time	Method
Change in Serum 25(OH)D concentration	0 and 2 months, 4 and 6 months

Secondary Outcome Measures

Name	Time	Method
Satisfaction with the vitamin D chewable tablets and pills.	0 and 2 months, 4 and 6 months	Satisfaction will be assessed using a questionnaire administered by the research team.
Adherence to the vitamin D chewable tablets and pills.	0 and 2 months, 4 and 6 months	This issue will be assessed by pill count.

Trial Locations

Locations (1)

CHU de Québec Research Centre, Laval University; 🇨🇦 Québec, Quebec, Canada