Kabul Vitamin D Supplementation Trial
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|ClinicalTrials.gov Identifier: NCT00548379|
Recruitment Status : Unknown
Verified May 2008 by London School of Hygiene and Tropical Medicine.
Recruitment status was: Active, not recruiting
First Posted : October 24, 2007
Last Update Posted : May 16, 2008
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 or disease||Intervention/treatment||Phase|
|Pneumonia Vitamin D Deficiency||Drug: vitamin D Drug: placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3048 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Vitamin D Supplementation on the Incidence of Pneumonia in Children in Afghanistan: a Randomized Controlled Trial|
|Study Start Date :||November 2007|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||July 2009|
Active Comparator: 1
Drug: vitamin D
vitamin D 100,000 units once in 3 months
|Placebo Comparator: 2||
olive oil 1ml
- incidence of pneumonia [ Time Frame: 18 months ]
- incidence of diarrhoea [ Time Frame: 18 months ]
- incidence of ricketts [ Time Frame: 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548379
|Aga Khan Health Services|
|Principal Investigator:||Daniel Chandramohan, MBBS MSc PhD||London School of Hygiene and 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|