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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-05-09

Brief Summary

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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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Detailed Description

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Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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wash-out

2 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Vitamin D chewable tablet supplementation

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

Group Type EXPERIMENTAL

Vitamin D chewable tablet supplementation

Intervention Type DRUG

Vitamin D pill supplementation

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

Group Type EXPERIMENTAL

Vitamin D pill supplementation

Intervention Type DRUG

Interventions

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Vitamin D chewable tablet supplementation

Intervention Type DRUG

Vitamin D pill supplementation

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes