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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02158598
Enrollment
38
Registered
2014-06-09
Start date
2014-06-30
Completion date
2018-05-09
Last updated
2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

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.

Interventions

DRUGVitamin D chewable tablet supplementation
DRUGVitamin D pill supplementation

Sponsors

Khlôros Technology
CollaboratorUNKNOWN
Anne-Sophie Morisset
CollaboratorUNKNOWN
CHU de Quebec-Universite Laval
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Change in Serum 25(OH)D concentration0 and 2 months, 4 and 6 months

Secondary

MeasureTime frameDescription
Satisfaction with the vitamin D chewable tablets and pills.0 and 2 months, 4 and 6 monthsSatisfaction will be assessed using a questionnaire administered by the research team.
Adherence to the vitamin D chewable tablets and pills.0 and 2 months, 4 and 6 monthsThis issue will be assessed by pill count.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026