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
Sponsor:
Collaborators:
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:
NCT00548379
First received: October 23, 2007
Last updated: May 15, 2008
Last verified: May 2008
  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 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Health Services
Aga Khan University
Maywand Hospital, Kabul
Investigators
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

No publications provided by London School of Hygiene and Tropical Medicine

Additional 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
pneumonia

Additional relevant MeSH terms:
Pneumonia
Vitamin D Deficiency
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 14, 2014