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Sponsors and Collaborators: |
London School of Hygiene and Tropical Medicine Wellcome Trust Aga Khan University Maywand Hospital, Kabul |
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Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00548379 |
Background: Pneumonia is the leading cause of childhood mortality, accounting for 19% of the 10.6 million deaths that occur each year1. Case-control studies from Ethiopia2 and India3 suggest that sub-clinical vitamin D deficiency may increase ten times the risk of pneumonia in children. We postulate that controlling childhood vitamin D deficiency has the potential to dramatically reduce the incidence of pneumonia and save >700,000 lives each year since vitamin D deficiency is widespread in developing countries.
Aim: To investigate whether 3-monthly oral supplementation of 100,000iu vitamin D reduces pneumonia and its consequences among children aged 1-12 months (followed for 18 months), living in a deprived area of Kabul, Afghanistan, where >70% of young children are vitamin D deficient (<8ng/dl). The effect of vitamin D on the incidence of other diseases, in particular diarrhea and rickets will also be investigated.
Methods: Randomised double-blind placebo-controlled trial: 3000 children will be randomised to receive either 6 doses of vitamin D or placebo. The first dose will be given at the start of autumn and the second and subsequent doses every 3 months thereafter; children will be followed for 18 months. Incidence of pneumonia will be ascertained though weekly home visits (active surveillance) and from attendances and admissions at the trial clinic and wards in the hospital serving the study area (passive surveillance).
Condition | Intervention | Phase |
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Pneumonia Vitamin D Deficiency |
Drug: vitamin D Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Vitamin D Supplementation on the Incidence of Pneumonia in Children in Afghanistan: a Randomized Controlled Trial |
Enrollment: | 3048 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Vitamin D
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Drug: vitamin D
vitamin D 100,000 units once in 3 months
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2: Placebo Comparator |
Drug: placebo
olive oil 1ml
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Ages Eligible for Study: | 1 Month to 11 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Afghanistan | |
Maywand Hospital | |
Kabul, Afghanistan | |
Aga Khan Health Services | |
Kabul, Afghanistan |
Principal Investigator: | Daniel Chandramohan, MBBS MSc PhD | London School of Hygiene & Tropical Medicine |
Principal Investigator: | Semira Manaseki-Holland, MRCP PhD | Agh Khan Health Services |
Principal Investigator: | Zulfiqar A Bhutta, MD | Aga khan University, Karachi |
Principal Investigator: | Zulf Mughal, MRCP | Manchester Childrens Hosptial |
Responsible Party: | Aga Khan Health Services, Afghanistan ( Semira Manaseki-Holland BMSci MBBS MFPHM MRCP MSc PhD, Chief Executive Officer for Central Asia, ) |
Study ID Numbers: | 1963, WT082476MA |
Study First Received: | October 23, 2007 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00548379 |
Health Authority: | Afghanistan: Ministry of Public Health |
vitamin D pneumonia |
Vitamin D Deficiency Vitamin D Malnutrition Respiratory Tract Infections Respiratory Tract Diseases Avitaminosis |
Lung Diseases Ergocalciferols Nutrition Disorders Pneumonia Deficiency Diseases |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |