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

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ClinicalTrials.gov Identifier: NCT01131858
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : April 5, 2012
Sponsor:
Information provided by (Responsible Party):
Peter Bergman, Karolinska University Hospital

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

Condition or disease Intervention/treatment Phase
Primary Immune Deficiency Disorder Drug: Vigantol Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Active Comparator: Vitamin D
Vigantol (cholecalciferol) 4000 IE/day
Drug: Vigantol
Vigantol 4000IU/day



Primary Outcome Measures :
  1. Infectious score [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Antimicrobial peptide expression in nasal fluid [ Time Frame: 12 months ]
  2. Serum levels of 25-OH Vitamin D3 [ Time Frame: 12 months ]
  3. Consumption of antibiotics [ Time Frame: 12 months ]
  4. Number of positive bacterial cultures in nasal swabs [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131858


Locations
Sweden
Karolinska Univerisity Hospital
Stockholm, Sweden, 18146
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Principal Investigator: Jan Andersson, MD/PhD Karolinska University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Bergman, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01131858     History of Changes
Other Study ID Numbers: 2009/1678-31/4
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: April 5, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents