Intermittent Preventive Treatment for Malaria in Infants in Navrongo Ghana

Malaria Clinical Trial

Official title:

Evaluation of the Safety and Effectiveness of EPI-linked Malaria Intermittent Chemotherapy and Iron Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857077
• Other study ID #: DFID-R7602
• Status: Completed
• Phase: N/A
• First received: March 5, 2009
• Last updated: January 25, 2017
• Start date: September 2000
• Est. completion date: June 2004

Study information

• Verified date: January 2017
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of the safety and effectiveness of malaria intermittent chemotherapy and iron supplementation delivered through Expanded Programme on Immunisation vaccination clinics.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2485
• Est. completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Anaemia
• Malaria

Intervention

Drug:
• Sulfadoxine-pyrimethamine

• Placebo

Locations

Country	Name	City	State
Ghana	Navrongo Health Research Centre	Navrongo	Upper East Region

Sponsors (5)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Department for International Development, United Kingdom, INDEPTH Network, Kintampo Health Research Centre, Ghana, Navrongo Health Research Centre, Navrongo, Ghana.

Country where clinical trial is conducted

Ghana, 

References & Publications (1)

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 transmissi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of anaemia
Secondary	incidence of clinical malaria
Secondary	incidence of severe disease and mortality
Secondary	prevalence of anaemia and parasitaemia
Secondary	incidence of adverse events