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Completed

NCT Number: NCT02158598

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Québec Research Centre, Laval University

Québec, Quebec, g1v 4g2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D chewable tablet supplementation

Drug

Vitamin D pill supplementation

Drug

Primary outcomes

  1. Change in Serum 25(OH)D concentration

    Time frame: 0 and 2 months, 4 and 6 months

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Anne-Sophie Morisset
  • Khlôros Technology

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jun 9, 2014
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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