Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels

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

NA

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-04-30

Brief Summary

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Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level.

The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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D2 2000 IU daily

Group Type ACTIVE_COMPARATOR

ergocalciferol 2000 IU orally, daily

Intervention Type DRUG

ergocalciferol 2000 IU orally, daily

D3 2000 IU daily

Group Type ACTIVE_COMPARATOR

cholecalciferol 2000 IU orally daily

Intervention Type DRUG

cholecalciferol 2000 IU orally everyday

D2 1000 IU + D3 1000 IU daily

Group Type ACTIVE_COMPARATOR

ergocal1000 IU & cholecal 1000 IU orally daily

Intervention Type DRUG

ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day

D2 25000 IU Q2wk

Group Type ACTIVE_COMPARATOR

ergocalciferol 25000 IU oraly every 2 weeks

Intervention Type DRUG

ergocalciferol 25000 IU oraly every 2 weeks

D3 25000 IU Q2wk

Group Type ACTIVE_COMPARATOR

Cholecalciferol 25000 IU orally every 2 weeks

Intervention Type DRUG

Cholecalciferol 25000 IU orally every 2 weeks

D2 50000 IU Q4wk

Group Type ACTIVE_COMPARATOR

ergocalciferol 50000 IU orally every 4 weeks

Intervention Type DRUG

ergocalciferol 50000 IU orally every 4 weeks

D3 50000 IU Q4wk

Group Type ACTIVE_COMPARATOR

Cholecalciferol 50000 orally every 4 weeks

Intervention Type DRUG

Cholecalciferol 50000 orally every 4 weeks

placebo daily

Group Type PLACEBO_COMPARATOR

placebo orally everyday

Intervention Type DRUG

placebo orally everyday

Interventions

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ergocalciferol 2000 IU orally, daily

Intervention Type DRUG

ergocalciferol 25000 IU oraly every 2 weeks

Intervention Type DRUG

ergocalciferol 50000 IU orally every 4 weeks

Intervention Type DRUG

ergocal1000 IU & cholecal 1000 IU orally daily

ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day

Intervention Type DRUG

cholecalciferol 2000 IU orally daily

cholecalciferol 2000 IU orally everyday

Intervention Type DRUG

Cholecalciferol 25000 IU orally every 2 weeks

Intervention Type DRUG

Cholecalciferol 50000 orally every 4 weeks

Intervention Type DRUG

placebo orally everyday

Intervention Type DRUG

Other Intervention Names

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ergocalciferol ergocalciferol ergocalciferol ergocalciferol and cholecalciferol cholecalciferol Cholecalciferol Cholecalciferol placebo

Eligibility Criteria

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Inclusion Criteria

* Healthy adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
* 25 OH vitamin D level between 20 to 50 nmol/L.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes