Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency (VITAPID)

Karolinska University Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Primary Immune Deficiency Disorder

Treatments: Drug: Vigantol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01131858

2009/1678-31/4

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Vitamin D

Active Comparator group

Description:

Vigantol (cholecalciferol) 4000 IE/day

Treatment:

Drug: Vigantol