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

July 27, 2018 updated by: Claudia Gagnon, CHU de Quebec-Universite Laval
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, g1v 4g2
        • CHU de Québec Research Centre, Laval University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: wash-out
2 months
Experimental: Vitamin D chewable tablet supplementation
A chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months.
Drug: Vitamin D chewable tablet supplementation
Experimental: Vitamin D pill supplementation
A vitamin D pill containing 1000 IU to be taken once a day for 2 months.
Drug: Vitamin D pill supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Serum 25(OH)D concentration
Time Frame: 0 and 2 months, 4 and 6 months
0 and 2 months, 4 and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Khlôros Technology
Anne-Sophie Morisset

Investigators

  • Principal Investigator: Claudia Gagnon, MD, CHU de Québec Research Centre and Laval University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

May 9, 2018

Study Registration Dates

First Submitted

June 2, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Actual)

July 30, 2018

Last Update Submitted That Met QC Criteria

July 27, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B14-03-1896

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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