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Completed

NCT Number: NCT01131858

Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency

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

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Key information

Conditions

Primary Immune Deficiency Disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Karolinska Univerisity Hospital

Stockholm, 18146, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vigantol

Drug

Vigantol 4000IU/day

Placebo

Drug

Placebo

Primary outcomes

  1. Infectious score

    Time frame: 12 months

Secondary outcomes

  1. Antimicrobial peptide expression in nasal fluid

    Time frame: 12 months

  2. Serum levels of 25-OH Vitamin D3

    Time frame: 12 months

  3. Consumption of antibiotics

    Time frame: 12 months

  4. Number of positive bacterial cultures in nasal swabs

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Official study title

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

Acronym: VITAPID

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 27, 2010
Registry last updated
Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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