Kabul Vitamin D Supplementation Trial

NCT00548379 | Unknown Phase 3 DMC

• 2 other identifiers: 1963WT082476MA
• Study Type: interventional
• Target: 3,048
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Pneumonia; Vitamin D Deficiency

Keywords

vitamin D; pneumonia

Outcome Measures

Primary Outcomes (1)

• incidence of pneumonia

  18 months

Secondary Outcomes (2)

• incidence of diarrhoea

  18 months

• incidence of ricketts

  18 months

Study Arms (2)

1

ACTIVE COMPARATOR

Vitamin D

Drug: vitamin D

2

PLACEBO COMPARATOR

Drug: placebo

Interventions

vitamin D DRUG

vitamin D 100,000 units once in 3 months

1

placebo DRUG

olive oil 1ml

2

Eligibility Criteria

• Age: 1 Month - 11 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• the family is likely to migrate out of the study area within the next 18 months
• the child has been diagnosed with rickets or known to have received a course of vitamin D treatment in the past 3 monDths.
• Child with Kwashiorkor or Marasmus.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Wellcome Trust: collaborator
• Aga Khan Health Services: collaborator
• Aga Khan University: collaborator
• Maywand Hospital, Kabul: collaborator

Study Sites (2)

Aga Khan Health Services

Kabul, Kabul, Afghanistan

Location

Maywand Hospital

Kabul, Afghanistan

Location

Related Publications (4)

• Crowe FL, Mughal MZ, Maroof Z, Berry J, Kaleem M, Abburu S, Walraven G, Masher MI, Chandramohan D, Manaseki-Holland S. Vitamin D for Growth and Rickets in Stunted Children: A Randomized Trial. Pediatrics. 2021 Jan;147(1):e20200815. doi: 10.1542/peds.2020-0815. Epub 2020 Dec 18.

  PMID: 33386335 DERIVED

• Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

  PMID: 33305842 DERIVED

• Aluisio AR, Maroof Z, Chandramohan D, Bruce J, Masher MI, Manaseki-Holland S, Ensink JH. Risk factors associated with recurrent diarrheal illnesses among children in Kabul, Afghanistan: a prospective cohort study. PLoS One. 2015 Feb 13;10(2):e0116342. doi: 10.1371/journal.pone.0116342. eCollection 2015.

  PMID: 25679979 DERIVED

• Manaseki-Holland S, Maroof Z, Bruce J, Mughal MZ, Masher MI, Bhutta ZA, Walraven G, Chandramohan D. Effect on the incidence of pneumonia of vitamin D supplementation by quarterly bolus dose to infants in Kabul: a randomised controlled superiority trial. Lancet. 2012 Apr 14;379(9824):1419-27. doi: 10.1016/S0140-6736(11)61650-4. Epub 2012 Apr 10.

  PMID: 22494826 DERIVED

MeSH Terms

Conditions

Pneumonia; Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 24, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 16, 2008

Record last verified: 2008-05

Locations

AF (2)