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
  Purpose

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


Condition Intervention Phase
Primary Immune Deficiency Disorder
Drug: Vigantol
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Infectious score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Active Comparator: Vitamin D
Vigantol (cholecalciferol) 4000 IE/day
Drug: Vigantol
Vigantol 4000IU/day

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Peter Bergman, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01131858     History of Changes
Other Study ID Numbers: 2009/1678-31/4
Study First Received: May 26, 2010
Last Updated: April 4, 2012
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on April 17, 2014