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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Bergman, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01131858
First received: May 26, 2010
Last updated: April 4, 2012
Last verified: April 2012

May 26, 2010
April 4, 2012
March 2010
June 2011   (final data collection date for primary outcome measure)
Infectious score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01131858 on ClinicalTrials.gov Archive Site
  • Antimicrobial peptide expression in nasal fluid [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Serum levels of 25-OH Vitamin D3 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Consumption of antibiotics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of positive bacterial cultures in nasal swabs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Antimicrobial peptide expression in nasal fluid [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Primary Immune Deficiency Disorder
  • Drug: Vigantol
    Vigantol 4000IU/day
  • Drug: Placebo
    Placebo
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Vitamin D
    Vigantol (cholecalciferol) 4000 IE/day
    Intervention: Drug: Vigantol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
June 2011
June 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01131858
2009/1678-31/4
Yes
Peter Bergman, Karolinska University Hospital
Karolinska University Hospital
Not Provided
Principal Investigator: Jan Andersson, MD/PhD Karolinska University Hospital
Karolinska University Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP