Kabul Vitamin D Supplementation Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Active, not recruiting
Wellcome Trust
Aga Khan Health Services
Aga Khan University
Maywand Hospital, Kabul
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
First received: October 23, 2007
Last updated: May 15, 2008
Last verified: May 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 Intervention Phase
Vitamin D Deficiency
Drug: vitamin D
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Vitamin D Supplementation on the Incidence of Pneumonia in Children in Afghanistan: a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • incidence of pneumonia [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of diarrhoea [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • incidence of ricketts [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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
Active Comparator: 1
Vitamin D
Drug: vitamin D
vitamin D 100,000 units once in 3 months
Placebo Comparator: 2 Drug: placebo
olive oil 1ml

  Show Detailed Description


Ages Eligible for Study:   1 Month to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 1 to 11 month old infants living in the study area
  2. caretakers are willing to give consent to take part in the study

Exclusion Criteria:

  1. the family is likely to migrate out of the study area within the next 18 months
  2. the child has been diagnosed with rickets or known to have received a course of vitamin D treatment in the past 3 monDths.
  3. Child with Kwashiorkor or Marasmus.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00548379

Aga Khan Health Services
Kabul, Afghanistan
Maywand Hospital
Kabul, Afghanistan
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Wellcome Trust
Aga Khan Health Services
Aga Khan University
Maywand Hospital, Kabul
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Semira Manaseki-Holland BMSci MBBS MFPHM MRCP MSc PhD, Chief Executive Officer for Central Asia,, Aga Khan Health Services, Afghanistan
ClinicalTrials.gov Identifier: NCT00548379     History of Changes
Other Study ID Numbers: 1963  WT082476MA 
Study First Received: October 23, 2007
Last Updated: May 15, 2008
Health Authority: Afghanistan: Ministry of Public Health

Keywords provided by London School of Hygiene and Tropical Medicine:
vitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Lung Diseases
Nutrition Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Vitamin D
Bone Density Conservation Agents
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016