Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01131858

Acronym

VITAPID

Enrollment

140

Registered

2010-05-27

Start date

2010-03-31

Completion date

2011-06-30

Last updated

2012-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Deficiency Disorder

Brief summary

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

Interventions

DRUGVigantol

Vigantol 4000IU/day

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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)

Design outcomes

Primary

Measure	Time frame
Infectious score	12 months

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026