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Completed

NCT Number: NCT03984890

Vitamin D3 For CGD Patients With BCGosis/Itis

When children with chronic granulomatous disease (CGD) got BCG infection the treatment would be a tough task. The goal of the proposed research is to observe weather vitamin D supplementation can help the CGD children get through this challenge.

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Key information

Conditions

Vitamin D3 BCG Chronic Disease Chronic-granulomatous Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Genetic Diseases, X-Linked Granulomatous Disease, Chronic Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Leukocyte Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Phagocyte Bactericidal Dysfunction

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Children's Hospital of Fudan University, Shanghai, Shanghai Municipality, China

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About this study

Chronic granulomatous disease (CGD) is one of primary immunodeficiency diseases. Due to the deficiency of the phagocyte nicotinamide adenine dinucleotide phosphate (NADPH) oxidase the respiratory burst of all types of phagocytic cells is badly impaired which lead to a susceptibility to infection among CGD patients.

BCG vaccine is wildly used in China to avoid severe tuberculosis infection. Children are supposed to get BCG vaccine injected within 24 hours after birth. When patients with CGD got the vaccination of BCG they will easily got infected. And due to the immunodeficiency of these children, the infection cannot be cure by normal treatment.

Vitamin D supplementation was used to treat tuberculosis in the pre-antibiotic era and is reported to have influence on immune system especially on monocytes and macrophages thus may help CGD children defend the BCG infection. In addition, studies show that 1,25-Dihydroxyvitamin D3 can induce nitric oxide synthase thus may up regulate NO production and help host defense against human tuberculosis without the help of NADPH oxidase. Other researches indicate that Vitamin D and the expression of vitamin D receptor may lead to induction of antimicrobial peptide such as LL-37 which help macrophages kill the intracellular Mycobacterium tuberculosis. These discoveries indicated that vitamin D may induce immune response against BCG in a nontraditional way. Therefore, when CGD patients face BCG infection, add vitamin D supplementation to the treatment may help them survive this challenge.

Since there have had clinical trials revealing that intermittent high dose vitamin D3 supplementation as 2.5mg per 14 days only receive positive effect on partial patients the investigators decide to choose a mild dose treatment as 800IU/d for 3 month to see if things get different in this way.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • less than 18 years' old
  • Diagnosed with CGD
  • Got BCG infection after vaccination

Exclusion criteria

  • Serum 25-(OH)-vit D >75 nmol/L (30 ng/mL)
  • Hyperphosphatemia
  • Hypercalcemia
  • Acute or chronic renal failure
  • Acute or chronic cardiac failure
  • Kidney stone

Treatment and study plan

Vitamin D3

Drug

Vitamin D3 drops 800IU/d for 3 months

Traditional treatment of CGD and TB

Drug

Anti-tuberculosis drugs, interferon-gamma

Primary outcomes

  1. Mortality

    Time frame: 8 weeks

    Death rate among patients

  2. Rate of Sputum Culture acid-fast bacilli microscopy Conversion

    Time frame: 8 weeks

    If sputum culture and acid-fast bacilli microscopy show positive results before treatments, compare the results before and after treatments to see if the rate that results changed from positive to negative differ between control group and vitamin D group

  3. Duration of Fever

    Time frame: 8 weeks

    Calculate the days suffer from fevers to show the severity of the infection and the efficacy of the treatment

  4. Number of Anti-tuberculosis Drugs Used in the Treatment

    Time frame: 8 weeks

    Calculate the number of anti-tuberculosis drugs used in the treatment to show the severity of the infection and the efficacy of the treatment

  5. Urine Protein

    Time frame: 8 weeks

    Urine protein quantitation

  6. Urine Calcium

    Time frame: 8 weeks

    Concentration of calcium in urine

  7. Serum Levels of 25-OH Vitamin D3

    Time frame: 8 weeks

    Concentration of 25-OH Vitamin D3 in serum

  8. Serum Levels of Calcium

    Time frame: 8 weeks

    Concentration of calcium in serum

Secondary outcomes

  1. Change in BMI

    Time frame: 1 year

    Evaluate the change in BMI by calculating weight(kg)/height(m)^2 before treatment and 1year after the treatment

  2. Frequency of Recurrent Infections

    Time frame: 1 year

    Use frequency of recurrent infections to evaluate long-term benefits

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

Effect of Vitamin D3 Supplementation on Chronic Granulomatous Disease Patients With BCGosis/Itis

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jun 13, 2019
Registry last updated
Jul 9, 2024

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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