Condition category
Infections and Infestations
Date applied
01/02/2006
Date assigned
01/02/2006
Last edited
21/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.who.int/

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

Results - basic reporting

Publication summary

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

  1. 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.

  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.

Additional files

Editorial Notes