The prevention of malaria and anaemia in infants through iron supplementation and intermittent malaria treatment administered through the Expanded Programme on Immunization (EPI) Scheme (Tanzania)

ISRCTN	ISRCTN88523834
DOI	https://doi.org/10.1186/ISRCTN88523834
Secondary identifying numbers	980483

Submission date: 01/02/2006
Registration date: 01/02/2006
Last edited: 21/04/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Melba Gomes
Scientific

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Phone	+41 (0)22 791 3813
Email	gomesm@who.int

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Ethics approval received on the 26th June 1998.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	26/06/1998
Completion date	26/06/2000

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Female
Target number of participants	340 infants in each group to be randomised, 680 total
Key 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.
Key exclusion criteria	Infants who are not permanent residents in Ifakara.
Date of first enrolment	26/06/1998
Date of final enrolment	26/06/2000

Locations

Countries of recruitment

Switzerland
Tanzania

Study participating centre

20, Avenue Appia

Geneva-27
CH 1211
Switzerland

Sponsor information

UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation

20, Avenue Appia
Geneva-27
CH 1211
Switzerland

Website	http://www.who.int/
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Research organisation

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results at	12/05/2001		Yes	No
Results article	follow-up results	01/04/2005		Yes	No