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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014