Vitamin D3 For CGD Patients With BCGosis/Itis

NCT03984890 | Completed Phase 2 DMC

• 1 other identifier: VDBCG
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Vitamin D3; Chronic-granulomatous Disease; BCG

Outcome Measures

Primary Outcomes (8)

• Mortality

  Death rate among patients

  8 weeks

• Rate of Sputum Culture acid-fast bacilli microscopy Conversion

  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

  8 weeks

• Duration of Fever

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

  8 weeks

• Number of Anti-tuberculosis Drugs Used in the Treatment

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

  8 weeks

• Urine Protein

  Urine protein quantitation

  8 weeks

• Urine Calcium

  Concentration of calcium in urine

  8 weeks

• Serum Levels of 25-OH Vitamin D3

  Concentration of 25-OH Vitamin D3 in serum

  8 weeks

• Serum Levels of Calcium

  Concentration of calcium in serum

  8 weeks

Secondary Outcomes (2)

• Change in BMI

  1 year

• Frequency of Recurrent Infections

  1 year

Study Arms (2)

Vitamin D Group

EXPERIMENTAL

Vitamin D3 Supplementation plus traditional treatment of CGD and TB

Drug: Vitamin D3; Drug: Traditional treatment of CGD and TB

Control Group

OTHER

Traditional treatment of CGD and TB without Vitamin D Supplementation

Drug: Traditional treatment of CGD and TB

Interventions

Vitamin D3 DRUG

Vitamin D3 drops 800IU/d for 3 months

Vitamin D Group

Traditional treatment of CGD and TB DRUG

Anti-tuberculosis drugs, interferon-gamma

Control Group; Vitamin D Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (2)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Related Publications (5)

• Martineau AR, Wilkinson KA, Newton SM, Floto RA, Norman AW, Skolimowska K, Davidson RN, Sorensen OE, Kampmann B, Griffiths CJ, Wilkinson RJ. IFN-gamma- and TNF-independent vitamin D-inducible human suppression of mycobacteria: the role of cathelicidin LL-37. J Immunol. 2007 Jun 1;178(11):7190-8. doi: 10.4049/jimmunol.178.11.7190.

  PMID: 17513768 BACKGROUND

• Rockett KA, Brookes R, Udalova I, Vidal V, Hill AV, Kwiatkowski D. 1,25-Dihydroxyvitamin D3 induces nitric oxide synthase and suppresses growth of Mycobacterium tuberculosis in a human macrophage-like cell line. Infect Immun. 1998 Nov;66(11):5314-21. doi: 10.1128/IAI.66.11.5314-5321.1998.

  PMID: 9784538 BACKGROUND

• Martineau AR, Timms PM, Bothamley GH, Hanifa Y, Islam K, Claxton AP, Packe GE, Moore-Gillon JC, Darmalingam M, Davidson RN, Milburn HJ, Baker LV, Barker RD, Woodward NJ, Venton TR, Barnes KE, Mullett CJ, Coussens AK, Rutterford CM, Mein CA, Davies GR, Wilkinson RJ, Nikolayevskyy V, Drobniewski FA, Eldridge SM, Griffiths CJ. High-dose vitamin D(3) during intensive-phase antimicrobial treatment of pulmonary tuberculosis: a double-blind randomised controlled trial. Lancet. 2011 Jan 15;377(9761):242-50. doi: 10.1016/S0140-6736(10)61889-2. Epub 2011 Jan 5.

  PMID: 21215445 BACKGROUND

• Liu PT, Stenger S, Li H, Wenzel L, Tan BH, Krutzik SR, Ochoa MT, Schauber J, Wu K, Meinken C, Kamen DL, Wagner M, Bals R, Steinmeyer A, Zugel U, Gallo RL, Eisenberg D, Hewison M, Hollis BW, Adams JS, Bloom BR, Modlin RL. Toll-like receptor triggering of a vitamin D-mediated human antimicrobial response. Science. 2006 Mar 24;311(5768):1770-3. doi: 10.1126/science.1123933. Epub 2006 Feb 23.

  PMID: 16497887 BACKGROUND

• Collaborative Group for the Meta-Analysis of Individual Patient Data in MDR-TB treatment-2017; Ahmad N, Ahuja SD, Akkerman OW, Alffenaar JC, Anderson LF, Baghaei P, Bang D, Barry PM, Bastos ML, Behera D, Benedetti A, Bisson GP, Boeree MJ, Bonnet M, Brode SK, Brust JCM, Cai Y, Caumes E, Cegielski JP, Centis R, Chan PC, Chan ED, Chang KC, Charles M, Cirule A, Dalcolmo MP, D'Ambrosio L, de Vries G, Dheda K, Esmail A, Flood J, Fox GJ, Frechet-Jachym M, Fregona G, Gayoso R, Gegia M, Gler MT, Gu S, Guglielmetti L, Holtz TH, Hughes J, Isaakidis P, Jarlsberg L, Kempker RR, Keshavjee S, Khan FA, Kipiani M, Koenig SP, Koh WJ, Kritski A, Kuksa L, Kvasnovsky CL, Kwak N, Lan Z, Lange C, Laniado-Laborin R, Lee M, Leimane V, Leung CC, Leung EC, Li PZ, Lowenthal P, Maciel EL, Marks SM, Mase S, Mbuagbaw L, Migliori GB, Milanov V, Miller AC, Mitnick CD, Modongo C, Mohr E, Monedero I, Nahid P, Ndjeka N, O'Donnell MR, Padayatchi N, Palmero D, Pape JW, Podewils LJ, Reynolds I, Riekstina V, Robert J, Rodriguez M, Seaworth B, Seung KJ, Schnippel K, Shim TS, Singla R, Smith SE, Sotgiu G, Sukhbaatar G, Tabarsi P, Tiberi S, Trajman A, Trieu L, Udwadia ZF, van der Werf TS, Veziris N, Viiklepp P, Vilbrun SC, Walsh K, Westenhouse J, Yew WW, Yim JJ, Zetola NM, Zignol M, Menzies D. Treatment correlates of successful outcomes in pulmonary multidrug-resistant tuberculosis: an individual patient data meta-analysis. Lancet. 2018 Sep 8;392(10150):821-834. doi: 10.1016/S0140-6736(18)31644-1.

  PMID: 30215381 BACKGROUND

MeSH Terms

Conditions

Granulomatous Disease, Chronic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Weili Yan, Ph.D

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: June 13, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)