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Kabul Vitamin D Supplementation Trial

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: London School of Hygiene and Tropical Medicine
Wellcome Trust
Aga Khan University
Maywand Hospital, Kabul
Information provided by: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00548379
  Purpose

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
Pneumonia
Vitamin D Deficiency
Drug: vitamin D
Drug: placebo
Phase III

MedlinePlus related topics:   Diarrhea    Pneumonia   

ChemIDplus related topics:   Vitamin D    Ergocalciferol   

U.S. FDA Resources

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

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

Show detailed description  Show Detailed Description

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548379

Locations
Afghanistan
Maywand Hospital    
      Kabul, Afghanistan
Aga Khan Health Services    
      Kabul, Afghanistan

Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Wellcome Trust
Aga Khan University
Maywand Hospital, Kabul

Investigators
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    
  More Information


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
First Received:   October 23, 2007
Last Updated:   May 15, 2008
ClinicalTrials.gov Identifier:   NCT00548379
Health Authority:   Afghanistan: Ministry of Public Health

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

Study placed in the following topic categories:
Vitamin D Deficiency
Vitamin D
Malnutrition
Respiratory Tract Infections
Respiratory Tract Diseases
Avitaminosis
Lung Diseases
Ergocalciferols
Nutrition Disorders
Pneumonia
Deficiency Diseases

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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