Contact information
Type
Scientific
Primary contact
Dr Melba Gomes
ORCID ID
Contact details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3813
gomesm@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
980483
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the impact of iron supplementation and the effectiveness of malaria intermittent treatment on the prevention of malaria and severe anaemia in infants.
Ethics approval
Ethics approval received on the 26th June 1998.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Malaria
Intervention
All children receive oral daily iron syrup at a dosage of 2 mg/kg/day and will be randomly allocated to receive either intermittent malaria treatment (sulfadoxine-pyrimethamine) or a placebo at DPT2, DPT3 and measles vaccinations.
Intervention type
Drug
Phase
Not Specified
Drug names
Sulfadoxine-pyrimethamine
Primary outcome measure
Incidence of clinical malaria and severe anaemia episodes in each group by 12 months of age.
Secondary outcome measures
1. Incidence of clinical malaria and severe anaemia episodes up to 18 months of age
2. Incidence of clinical malaria and severe anaemia from 10 to 18 months of age
3. Prevalence of malaria parasitaemia at 12 and 18 months of age
4. Prevalence of severe and moderate anaemia at 12 and 18 months of age
5. Total number of admissions and outpatient attendances
Overall trial start date
26/06/1998
Overall trial end date
26/06/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All children who attend the Mother and Child Health (MCH) clinic for their second Diphtheria, Pertussis, Tetanus (DPT) and polio immunisations and who are permanent residents in the study area of Ifakara town.
Participant type
Patient
Age group
Child
Gender
Female
Target number of participants
340 infants in each group to be randomised, 680 total
Participant exclusion criteria
Infants who are not permanent residents in Ifakara.
Recruitment start date
26/06/1998
Recruitment end date
26/06/2000
Locations
Countries of recruitment
Tanzania
Trial participating centre
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Sponsor details
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2001 results at http://www.ncbi.nlm.nih.gov/pubmed/11377597
2. 2005 follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/15850632
Publication citations
-
Results at
Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P, Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial., Lancet, 2001, 357, 9267, 1471-1477, doi: 10.1016/S0140-6736(00)04643-2.
-
Schellenberg D, Menendez C, Aponte JJ, Kahigwa E, Tanner M, Mshinda H, Alonso P, Intermittent preventive antimalarial treatment for Tanzanian infants: follow-up to age 2 years of a randomised, placebo-controlled trial., Lancet, 365, 9469, 1481-1483, doi: 10.1016/S0140-6736(05)66418-5.