Is Vitamin D2 Treatment-associated Decrease in 25(OH)D3 Level a Reciprocal Phenomena?

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2017-11-20

Brief Summary

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Several studies have demonstrated that D2 treatment is associated with a decrease in 25(OH)D3 level and therefore have proposed that D3 would be preferable in term of raising total 25(OH)D level. The investigators postulate that the D2 treatment-associated decrease in 25(OH)D3 level may be related to an increase in total 25(OH)D level rather than being specific to D2 treatment, and thus there would be a D3 treatment-associated decrease in 25(OH)D2 level.

The investigators plan to conduct a double-blind placebo-controlled trial to examine the effect of D3 treatment on 25(OH)D2 level and the effect of D2 treatment on 25(OH)D3 leve

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Detailed Description

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Conditions

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Vitamin D Deficiency 25-Hydroxyvitamin D Concentration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group-2-D3

Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to vitamin D3

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

Single oral dose of 50,000 IU of vitamin D3

Vitamin D2

Intervention Type DRUG

Single oral dose of 50,000 IU of vitamin D2

Group-2-Placebo

Subjects with total 25(OH)D more= 20 nmol/l and less= 40 nmol/l will receive vitamin D2 then randomly assigned to placebo oral capsule.

Group Type PLACEBO_COMPARATOR

Vitamin D2

Intervention Type DRUG

Single oral dose of 50,000 IU of vitamin D2

Placebo oral capsule

Intervention Type DRUG

Placebo oral capsule

Group-1-D2

Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less= 65 nmol/l will be randomly assigned to vitamin D2.

Group Type EXPERIMENTAL

Vitamin D2

Intervention Type DRUG

Single oral dose of 50,000 IU of vitamin D2

Group-1-Placebo

Subjects with 25(OH)D3 more= 40 nmol/l and total 25(OH)D less =65 nmol/l will be randomly assigned to placebo oral capsule.

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo oral capsule

Interventions

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Vitamin D3

Single oral dose of 50,000 IU of vitamin D3

Intervention Type DRUG

Vitamin D2

Single oral dose of 50,000 IU of vitamin D2

Intervention Type DRUG

Placebo oral capsule

Intervention Type DRUG

Other Intervention Names

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cholecalciferol Ergocalciferol

Eligibility Criteria

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Inclusion Criteria

* non-pregnant adults (age ≥18 years)
* healthy
* total 25(OH)D level between 20 to 65 nmol/L.
* living in Riyadh area

Exclusion Criteria

* consumption of more than one serving of milk daily
* taking vitamin D supplements
* habitual weekly sun exposure of 10 hours or more
* history of granulomatous, liver, or kidney disease
* taking anticonvulsants, barbiturates, or steroids

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes