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

NCT02158598 | Completed Phase 4

• 1 other identifier: B14-03-1896
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in Serum 25(OH)D concentration

  0 and 2 months, 4 and 6 months

Secondary Outcomes (2)

• Satisfaction with the vitamin D chewable tablets and pills.

  0 and 2 months, 4 and 6 months

• Adherence to the vitamin D chewable tablets and pills.

  0 and 2 months, 4 and 6 months

Study Arms (3)

wash-out

NO INTERVENTION

2 months

Vitamin D chewable tablet supplementation

EXPERIMENTAL

A chewable vitamin D tablet containing 1000 IU to be taken once a day for 2 months.

Drug: Vitamin D chewable tablet supplementation

Vitamin D pill supplementation

EXPERIMENTAL

A vitamin D pill containing 1000 IU to be taken once a day for 2 months.

Drug: Vitamin D pill supplementation

Interventions

Vitamin D chewable tablet supplementation DRUG

Vitamin D chewable tablet supplementation

Vitamin D pill supplementation DRUG

Vitamin D pill supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian men and women;
• Aged 18 years and older;
• Having a serum 25(OH)D concentration of 75 nmol/L or less.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Khlôros Technology: collaborator
• Anne-Sophie Morisset: collaborator

Study Sites (1)

CHU de Québec Research Centre, Laval University

Québec, Quebec, g1v 4g2, Canada

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D; Dietary Supplements

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Claudia Gagnon, MD

  CHU de Québec Research Centre and Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 9, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: May 9, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

CA (1)