Back to resultsComparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Vitamin D chewable tablet supplementation
Vitamin D pill supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility 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.
Sites / Locations
- CHU de Québec Research Centre, Laval University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
wash-out
Vitamin D chewable tablet supplementation
Vitamin D pill supplementation
Arm Description
2 months
A chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months.
A vitamin D pill containing 1000 IU to be taken once a day for 2 months.
Outcomes
Primary Outcome Measures
Change in Serum 25(OH)D concentration
Secondary Outcome Measures
Satisfaction with the vitamin D chewable tablets and pills.
Satisfaction will be assessed using a questionnaire administered by the research team.
Adherence to the vitamin D chewable tablets and pills.
This issue will be assessed by pill count.
Full Information
NCT ID
NCT02158598
First Posted
June 2, 2014
Last Updated
July 27, 2018
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Khlôros Technology, Anne-Sophie Morisset
1. Study Identification
Unique Protocol Identification Number
NCT02158598
Brief Title
Comparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
May 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Khlôros Technology, Anne-Sophie Morisset
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
wash-out
Arm Type
No Intervention
Arm Description
2 months
Arm Title
Vitamin D chewable tablet supplementation
Arm Type
Experimental
Arm Description
A chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months.
Arm Title
Vitamin D pill supplementation
Arm Type
Experimental
Arm Description
A vitamin D pill containing 1000 IU to be taken once a day for 2 months.
Intervention Type
Drug
Intervention Name(s)
Vitamin D chewable tablet supplementation
Intervention Type
Drug
Intervention Name(s)
Vitamin D pill supplementation
Primary Outcome Measure Information:
Title
Change in Serum 25(OH)D concentration
Time Frame
0 and 2 months, 4 and 6 months
Secondary Outcome Measure Information:
Title
Satisfaction with the vitamin D chewable tablets and pills.
Description
Satisfaction will be assessed using a questionnaire administered by the research team.
Time Frame
0 and 2 months, 4 and 6 months
Title
Adherence to the vitamin D chewable tablets and pills.
Description
This issue will be assessed by pill count.
Time Frame
0 and 2 months, 4 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Gagnon, MD
Organizational Affiliation
CHU de Québec Research Centre and Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Québec Research Centre, Laval University
City
Québec
State/Province
Quebec
ZIP/Postal Code
g1v 4g2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparison of Changes in Serum 25(OH)D Concentrations Following Vitamin D Supplementation With Chewable Tablets Versus Pills
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