Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

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

PHASE1/PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-06-30

Brief Summary

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Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients with primary immunodeficiency.

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Detailed Description

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Conditions

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Primary Immune Deficiency Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Vitamin D

Vigantol (cholecalciferol) 4000 IE/day

Group Type ACTIVE_COMPARATOR

Vigantol

Intervention Type DRUG

Vigantol 4000IU/day

Interventions

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Vigantol

Vigantol 4000IU/day

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18-75
* Increased number of respiratory tract infections
* At least 42 days of infections during 2008 or 2009
* S-25 OH vitamin D3 \< 250 nM
* Not planning a pregnancy during the coming year
* Accepting the use of contraceptives during 1 year

Exclusion Criteria

* Continuous antibiotic treatment
* Hypercalcemia
* Sarcoidosis
* Kidney disease
* Tuberculosis
* Pregnancy
* Kidney stone
* Heart medication (glycosides)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No