Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

Karolinska University Hospital140 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

140

Conditions

Primary Immune Deficiency Disorder

Interventions

VigantolDRUG

Vigantol 4000IU/day

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Karolinska Univerisity Hospital

Stockholm, Sweden

Outcomes

Primary Outcomes

Infectious score

Time frame: 12 months

Secondary Outcomes

Antimicrobial peptide expression in nasal fluid

Time frame: 12 months

Serum levels of 25-OH Vitamin D3

Time frame: 12 months

Consumption of antibiotics

Time frame: 12 months

Number of positive bacterial cultures in nasal swabs

Time frame: 12 months

Data from ClinicalTrials.gov

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