Vitamin D3 For CGD Patients With BCGosis/Itis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2023-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Vitamin D3 Chronic-granulomatous Disease BCG

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D Group

Vitamin D3 Supplementation plus traditional treatment of CGD and TB

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

Vitamin D3 drops 800IU/d for 3 months

Traditional treatment of CGD and TB

Intervention Type DRUG

Anti-tuberculosis drugs, interferon-gamma

Control Group

Traditional treatment of CGD and TB without Vitamin D Supplementation

Group Type OTHER

Traditional treatment of CGD and TB

Intervention Type DRUG

Anti-tuberculosis drugs, interferon-gamma

Interventions

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Vitamin D3

Vitamin D3 drops 800IU/d for 3 months

Intervention Type DRUG

Traditional treatment of CGD and TB

Anti-tuberculosis drugs, interferon-gamma

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. less than 18 years' old
2. Diagnosed with CGD
3. Got BCG infection after vaccination

Exclusion Criteria

1. Serum 25-(OH)-vit D \>75 nmol/L (30 ng/mL)
2. Hyperphosphatemia
3. Hypercalcemia
4. Acute or chronic renal failure
5. Acute or chronic cardiac failure
6. Kidney stone

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No