Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids)
ABSTRACT: Objectives: To determine whether weekly oral supplementation with 10,000 IU vitamin D3 for 3 years reduces the risk of sensitization to M. tuberculosis in South African schoolchildren aged 6-11 years with negative QuantiFERON-tuberculosis (TB) Gold Plus (QFT-Plus) assay results at baselin...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-09-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971223005623 |
| _version_ | 1827875780608131072 |
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| author | Keren Middelkoop Justine Stewart Neil Walker Carmen Delport David A. Jolliffe Anna K. Coussens James Nuttall Jonathan C.Y. Tang William D. Fraser Christopher J. Griffiths Geeta Trilok Kumar Suzanne Filteau Richard L. Hooper Robert J. Wilkinson Linda-Gail Bekker Adrian R. Martineau |
| author_facet | Keren Middelkoop Justine Stewart Neil Walker Carmen Delport David A. Jolliffe Anna K. Coussens James Nuttall Jonathan C.Y. Tang William D. Fraser Christopher J. Griffiths Geeta Trilok Kumar Suzanne Filteau Richard L. Hooper Robert J. Wilkinson Linda-Gail Bekker Adrian R. Martineau |
| author_sort | Keren Middelkoop |
| collection | DOAJ |
| description | ABSTRACT: Objectives: To determine whether weekly oral supplementation with 10,000 IU vitamin D3 for 3 years reduces the risk of sensitization to M. tuberculosis in South African schoolchildren aged 6-11 years with negative QuantiFERON-tuberculosis (TB) Gold Plus (QFT-Plus) assay results at baseline. Methods: We conducted a phase 3 randomized placebo-controlled trial in 1682 children attending 23 primary schools in Cape Town. The primary outcome was a positive end-trial QFT-Plus result, analyzed using a mixed effects logistic regression model with the school of attendance included as a random effect. Results: 829 vs. 853 QFT-Plus-negative children were randomized to receive vitamin D3 vs. placebo, respectively. Mean end-study 25(OH)D concentrations in participants randomized to vitamin D vs. placebo were 104.3 vs 64.7 nmol/l, respectively (95% confidence interval for difference, 37.6 to 41.9 nmol/l). A total of 76/667 (11.4%) participants allocated to vitamin D vs. 89/687 (13.0%) participants allocated to placebo tested QFT-Plus positive at 3-year follow-up (adjusted odds ratio 0.86, 95% confidence interval 0.62-1.19, P = 0.35). Conclusion: Weekly oral supplementation with 10,000 IU vitamin D3 for 3 years elevated serum 25(OH)D concentrations among QFT-Plus-negative Cape Town schoolchildren but did not reduce their risk of QFT-Plus conversion. |
| first_indexed | 2024-03-12T17:12:53Z |
| format | Article |
| id | doaj.art-f36b708fb8694610b7528f5eaa36a2a4 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-03-12T17:12:53Z |
| publishDate | 2023-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-f36b708fb8694610b7528f5eaa36a2a42023-08-06T04:36:40ZengElsevierInternational Journal of Infectious Diseases1201-97122023-09-011346370Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids)Keren Middelkoop0Justine Stewart1Neil Walker2Carmen Delport3David A. Jolliffe4Anna K. Coussens5James Nuttall6Jonathan C.Y. Tang7William D. Fraser8Christopher J. Griffiths9Geeta Trilok Kumar10Suzanne Filteau11Richard L. Hooper12Robert J. Wilkinson13Linda-Gail Bekker14Adrian R. Martineau15Desmond Tutu HIV Centre, Institute of Infectious Diseases & Molecular Medicine, University of Cape Town, Observatory, South Africa; Department of Medicine, University of Cape Town, Cape Town, South AfricaDesmond Tutu HIV Centre, Institute of Infectious Diseases & Molecular Medicine, University of Cape Town, Observatory, South Africa; Department of Medicine, University of Cape Town, Cape Town, South AfricaWolfson Institute of Population Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UKDesmond Tutu HIV Centre, Institute of Infectious Diseases & Molecular Medicine, University of Cape Town, Observatory, South AfricaBlizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UKWellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa; Infectious Diseases and Immune Defense Division, Walter and Eliza Hall Institute of Medical Research, Parkville, AustraliaPaediatric Infectious Diseases Unit, Red Cross War Memorial Children's Hospital and the Department of Paediatrics and Child Health, University of Cape Town, Cape Town, South AfricaNorwich Medical School, University of East Anglia, Norwich Research Park, Norwich, UK; Departments of Laboratory Medicine, Clinical Biochemistry, and Departments of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UKNorwich Medical School, University of East Anglia, Norwich Research Park, Norwich, UK; Departments of Laboratory Medicine, Clinical Biochemistry, and Departments of Diabetes and Endocrinology, Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UKWolfson Institute of Population Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UKDelhi School of Public Health, Institute of Eminence, University of Delhi, Delhi, India; Trivedi School of Biosciences, Ashoka University, Sonipat, IndiaFaculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UKWolfson Institute of Population Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UKWellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa; The Francis Crick Institute, London, UK; Imperial College London, London, UKDesmond Tutu HIV Centre, Institute of Infectious Diseases & Molecular Medicine, University of Cape Town, Observatory, South AfricaBlizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK; Corresponding author: Tel: +44 207 882 7242.ABSTRACT: Objectives: To determine whether weekly oral supplementation with 10,000 IU vitamin D3 for 3 years reduces the risk of sensitization to M. tuberculosis in South African schoolchildren aged 6-11 years with negative QuantiFERON-tuberculosis (TB) Gold Plus (QFT-Plus) assay results at baseline. Methods: We conducted a phase 3 randomized placebo-controlled trial in 1682 children attending 23 primary schools in Cape Town. The primary outcome was a positive end-trial QFT-Plus result, analyzed using a mixed effects logistic regression model with the school of attendance included as a random effect. Results: 829 vs. 853 QFT-Plus-negative children were randomized to receive vitamin D3 vs. placebo, respectively. Mean end-study 25(OH)D concentrations in participants randomized to vitamin D vs. placebo were 104.3 vs 64.7 nmol/l, respectively (95% confidence interval for difference, 37.6 to 41.9 nmol/l). A total of 76/667 (11.4%) participants allocated to vitamin D vs. 89/687 (13.0%) participants allocated to placebo tested QFT-Plus positive at 3-year follow-up (adjusted odds ratio 0.86, 95% confidence interval 0.62-1.19, P = 0.35). Conclusion: Weekly oral supplementation with 10,000 IU vitamin D3 for 3 years elevated serum 25(OH)D concentrations among QFT-Plus-negative Cape Town schoolchildren but did not reduce their risk of QFT-Plus conversion.http://www.sciencedirect.com/science/article/pii/S1201971223005623Vitamin DTuberculosisRandomized controlled trialInterferon-gamma release assay |
| spellingShingle | Keren Middelkoop Justine Stewart Neil Walker Carmen Delport David A. Jolliffe Anna K. Coussens James Nuttall Jonathan C.Y. Tang William D. Fraser Christopher J. Griffiths Geeta Trilok Kumar Suzanne Filteau Richard L. Hooper Robert J. Wilkinson Linda-Gail Bekker Adrian R. Martineau Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids) International Journal of Infectious Diseases Vitamin D Tuberculosis Randomized controlled trial Interferon-gamma release assay |
| title | Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids) |
| title_full | Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids) |
| title_fullStr | Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids) |
| title_full_unstemmed | Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids) |
| title_short | Vitamin D supplementation to prevent tuberculosis infection in South African schoolchildren: multicenter phase 3 double-blind randomized placebo-controlled trial (ViDiKids) |
| title_sort | vitamin d supplementation to prevent tuberculosis infection in south african schoolchildren multicenter phase 3 double blind randomized placebo controlled trial vidikids |
| topic | Vitamin D Tuberculosis Randomized controlled trial Interferon-gamma release assay |
| url | http://www.sciencedirect.com/science/article/pii/S1201971223005623 |
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