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

April 4, 2012 updated by: Peter Bergman, Karolinska University Hospital

A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 18146
        • Karolinska Univerisity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infectious score
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Antimicrobial peptide expression in nasal fluid
Time Frame: 12 months
12 months
Serum levels of 25-OH Vitamin D3
Time Frame: 12 months
12 months
Consumption of antibiotics
Time Frame: 12 months
12 months
Number of positive bacterial cultures in nasal swabs
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Jan Andersson, MD/PhD, Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 26, 2010

First Posted (Estimate)

May 27, 2010

Study Record Updates

Last Update Posted (Estimate)

April 5, 2012

Last Update Submitted That Met QC Criteria

April 4, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/1678-31/4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Immune Deficiency Disorder

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe