Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
VITAPID
A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
1 other identifier
interventional
140
1 country
1
Brief Summary
Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients with primary immunodeficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 26, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedApril 5, 2012
April 1, 2012
1.3 years
May 26, 2010
April 4, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Infectious score
12 months
Secondary Outcomes (4)
Antimicrobial peptide expression in nasal fluid
12 months
Serum levels of 25-OH Vitamin D3
12 months
Consumption of antibiotics
12 months
Number of positive bacterial cultures in nasal swabs
12 months
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
Vitamin D
ACTIVE COMPARATORVigantol (cholecalciferol) 4000 IE/day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Continuous antibiotic treatment
- Hypercalcemia
- Sarcoidosis
- Kidney disease
- Tuberculosis
- Pregnancy
- Kidney stone
- Heart medication (glycosides)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska Univerisity Hospital
Stockholm, 18146, Sweden
Related Publications (2)
Bergman P, Norlin AC, Hansen S, Bjorkhem-Bergman L. Vitamin D supplementation improves well-being in patients with frequent respiratory tract infections: a post hoc analysis of a randomized, placebo-controlled trial. BMC Res Notes. 2015 Sep 29;8:498. doi: 10.1186/s13104-015-1504-2.
PMID: 26419363DERIVEDBergman P, Norlin AC, Hansen S, Bjorkhem-Bergman L. Vitamin D supplementation to patients with frequent respiratory tract infections: a post hoc analysis of a randomized and placebo-controlled trial. BMC Res Notes. 2015 Aug 30;8:391. doi: 10.1186/s13104-015-1378-3.
PMID: 26319134DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Andersson, MD/PhD
Karolinska University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 26, 2010
First Posted
May 27, 2010
Study Start
March 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
April 5, 2012
Record last verified: 2012-04