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Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana

This study has been completed.
Sponsor:
Collaborators:
Navrongo Health Research Centre, Navrongo, Ghana.
Kintampo Health Research Centre, Ghana
INDEPTH Network
Department for International Development, United Kingdom
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00857077
First received: March 5, 2009
Last updated: January 25, 2017
Last verified: January 2017

March 5, 2009
January 25, 2017
September 2000
Not Provided
incidence of anaemia
Same as current
Complete list of historical versions of study NCT00857077 on ClinicalTrials.gov Archive Site
  • incidence of clinical malaria
  • incidence of severe disease and mortality
  • prevalence of anaemia and parasitaemia
  • incidence of adverse events
Same as current
Not Provided
Not Provided
 
Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana
Evaluation of the Safety and Effectiveness of EPI-linked Malaria Intermittent Chemotherapy and Iron Supplementation
Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron supplementation delivered through Expanded Programme on Immunisation vaccination clinics.
Anaemia is one of the main disease burdens of children in developing countries. Severe anaemia is often fatal, while moderate anaemia leads to growth and cognitive disorders. The incidence of anaemia in children is extremely high in malaria endemic areas since episodes of clinical malaria and asymptomatic parasitaemia result in red cell destruction. It has been shown in Tanzania that the incidence of severe anaemia in infants can be reduced by 30% by regular administration of iron supplements, and by 60% if regular malaria chemoprophylaxis is given in addition. One way to operationalise this research finding, with minimal additional cost to governments and communities, is to link the distribution of iron and antimalarial drugs to the EPI programme. We propose a community-randomised trial to study the effectiveness of intermittent iron supplements and malaria chemotherapy in reducing the incidence of anaemia and clinical malaria, and to investigate any possible interactions of iron and antimalarial drugs with EPI vaccines. The study will have two arms: children in both arms will receive monthly supplies of twice weekly iron supplements when they attend EPI and growth monitoring clinics. In addition, children in arm 1 will receive a placebo when they receive Polio/DPT 2, Polio/DPT 3 and measles vaccines, while those in arm 2 will receive sulfadoxine-pyrimethamine (SP). The baseline incidence of anaemia and malaria, and immune response to EPI vaccines, will be estimated in a sample of children from a non-intervention area adjacent to the study area. The immune response to EPI vaccines, drug side-effects, and the incidence of anaemia and malaria will be compared between the two arms of the study and with the non-intervention area. Any possible 'rebound' in malaria incidence due to impairment of immunity will be monitored and treated during the six months after stopping the chemotherapy and supplementation.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
  • Anaemia
  • Malaria
  • Drug: Sulfadoxine-pyrimethamine
  • Drug: Placebo
  • Placebo Comparator: 1 Placebo
    Intervention: Drug: Placebo
  • Active Comparator: 2 Sulfadoxine-pyrimethamine (SP)
    Intervention: Drug: Sulfadoxine-pyrimethamine
Chandramohan D, Owusu-Agyei S, Carneiro I, Awine T, Amponsa-Achiano K, Mensah N, Jaffar S, Baiden R, Hodgson A, Binka F, Greenwood B. Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana. BMJ. 2005 Oct 1;331(7519):727-33.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2485
June 2004
Not Provided

Inclusion Criteria:

  • All infants living in study clusters without a history of allergy to sulfadoxine-pyrimethamine were eligible for enrollment in the study.

Exclusion Criteria:

  • History of allergy to sulfadoxine-pyrimethamine.
Sexes Eligible for Study: All
2 Months to 24 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Ghana
 
 
NCT00857077
DFID-R7602
Yes
Not Provided
Not Provided
Not Provided
Brian Greenwood, London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • Navrongo Health Research Centre, Navrongo, Ghana.
  • Kintampo Health Research Centre, Ghana
  • INDEPTH Network
  • Department for International Development, United Kingdom
Principal Investigator: Daniel Chandramohan, MD; PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Brian Greenwood, MD London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP