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

Vitamin D Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158598
• Other study ID #: B14-03-1896
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: May 9, 2018

Study information

• Verified date: July 2018
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 9, 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D chewable tablet supplementation

• Vitamin D pill supplementation

Locations

Country	Name	City	State
Canada	CHU de Québec Research Centre, Laval University	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	Anne-Sophie Morisset, Khlôros Technology

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum 25(OH)D concentration		0 and 2 months, 4 and 6 months
Secondary	Satisfaction with the vitamin D chewable tablets and pills.	Satisfaction will be assessed using a questionnaire administered by the research team.	0 and 2 months, 4 and 6 months
Secondary	Adherence to the vitamin D chewable tablets and pills.	This issue will be assessed by pill count.	0 and 2 months, 4 and 6 months