search
Back to results

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

Primary Purpose

Primary Immune Deficiency Disorder

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Vigantol
Placebo
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Primary Immune Deficiency Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Karolinska Univerisity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Vitamin D

Arm Description

Placebo

Vigantol (cholecalciferol) 4000 IE/day

Outcomes

Primary Outcome Measures

Infectious score

Secondary Outcome Measures

Antimicrobial peptide expression in nasal fluid
Serum levels of 25-OH Vitamin D3
Consumption of antibiotics
Number of positive bacterial cultures in nasal swabs

Full Information

First Posted
May 26, 2010
Last Updated
April 4, 2012
Sponsor
Karolinska University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01131858
Brief Title
Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
Acronym
VITAPID
Official Title
A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Vigantol (cholecalciferol) 4000 IE/day
Intervention Type
Drug
Intervention Name(s)
Vigantol
Intervention Description
Vigantol 4000IU/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Infectious score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Antimicrobial peptide expression in nasal fluid
Time Frame
12 months
Title
Serum levels of 25-OH Vitamin D3
Time Frame
12 months
Title
Consumption of antibiotics
Time Frame
12 months
Title
Number of positive bacterial cultures in nasal swabs
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Andersson, MD/PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Univerisity Hospital
City
Stockholm
ZIP/Postal Code
18146
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26419363
Citation
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.
Results Reference
derived
PubMed Identifier
26319134
Citation
Bergman 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.
Results Reference
derived

Learn more about this trial

Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

We'll reach out to this number within 24 hrs