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NCT01131858 Clinical Trial

Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

Primary Immune Deficiency Disorder Clinical Trial

— VITAPID  

Official title:
A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01131858
Other study ID # 2009/1678-31/4
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 26, 2010
Last updated April 4, 2012
Start date March 2010
Est. completion date June 2011

Study information
Verified date April 2012
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Vigantol
Vigantol 4000IU/day
• Placebo
Placebo

Locations
Country Name City State
Sweden Karolinska Univerisity Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Infectious score 12 months No
Secondary Antimicrobial peptide expression in nasal fluid 12 months No
Secondary Serum levels of 25-OH Vitamin D3 12 months Yes
Secondary Consumption of antibiotics 12 months No
Secondary Number of positive bacterial cultures in nasal swabs 12 months No
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