Magnitude of Changes in 25 OH Vitamin D3 Levels After Vitamin D3 Supplementation

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

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-08-31

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. The determination of the appropriate dose of vitamin D supplement is essential for management of vitamin D deficiency as well as for designing vitamin D fortification programs. The increments in 25 OH vitamin D levels following various doses of vitamin D supplement for different genders, body weights, and starting 25 OH vitamin D level have not been well defined. The time course of depletion of repleted vitamin D stores is also not known.

The investigators plan to conduct a double blind randomized study on 9 cohorts to determine levels of 25 OH vitamin D following supplementation with different doses of vitamin D3 for 5 months and their withdrawal for 3 months.

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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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vitamin D3 1000 IU

Group Type ACTIVE_COMPARATOR

vitamin D3 1000 IU orally daily for 5 months

Intervention Type DRUG

Vitamin D3 3000 IU

Group Type ACTIVE_COMPARATOR

vitamin D3 3000 IU orally daily for 5 months

Intervention Type DRUG

Vitamin D3 5000 IU

Group Type ACTIVE_COMPARATOR

vitamin D3 5000 IU orally daily for 5 months

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo orally daily for 5 months

Intervention Type DRUG

Interventions

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vitamin D3 1000 IU orally daily for 5 months

Intervention Type DRUG

vitamin D3 3000 IU orally daily for 5 months

Intervention Type DRUG

vitamin D3 5000 IU orally daily for 5 months

Intervention Type DRUG

Placebo orally daily for 5 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
* Individuals with with total 25 OH vitamin D level exceeding 100 nmol/l will be excluded from the study. Individuals with 25 OH vitamin D levels less than 20 nmol/L will be excluded from the placebo arm.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes