Condition category
Haematological Disorders
Date applied
10/04/2012
Date assigned
16/05/2012
Last edited
19/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Iron supplementation is an important public health intervention. However, in areas where malaria is common, iron supplementation may not be without risk because iron can stimulate the growth of malaria parasites. The aim of this study is to compare the incidence of malaria between children given iron supplementation and children not given iron supplementation.

Who can participate?
School age children (6-18 years old) tested as not infected with malaria.

What does the study involve?
The children will be randomly allocated to receive Albendazole (a drug to treat infections caused by worms) for three consecutive days in combination with either iron supplementation or a matching placebo (dummy drug) for 6 days per week for a total of 8 weeks.

What are the possible benefits and risks of participating?
Participants will receive anti-worm treatment for worm infections and iron treatment for their anemia. The iron tablet is given in individual doses based on body weight and under supervision of a medical doctor, so there is little or no risk of dangers from the side effects.

Where is the study run from?
Nangapanda Region, District of Ende, Flores Island, Indonesia.

When is the study starting and how long is it expected to run for?
The study ran from July 2011 until January 2012.

Who is funding the study?
Nutricia Research Foundation (Netherlands).

Who is the main contact?
Prof. Maria Yazdanabkshsh
m.yazdanbakhsh@lumc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Prof Maria Yazdanbakhsh

ORCID ID

Contact details

Department of Parasitology
Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2010-26

Study information

Scientific title

Towards safe and effective iron supplementation in malaria endemic areas: randomized double-blind placebo controlled trial

Acronym

Study hypothesis

Iron supplementation in anemic subjects with submicroscopic malaria increases hemoglobin levels but does not increase parasitaemia.

Ethics approval

Ethical Committee of Faculty of Medicine, University of Indonesia, 08 March 2010, ref: 96/PT02.FK/ETIK/2010, addendum ref: 459/PT02.FK/43/N/2011

Study design

Randomized placebo controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anemia, malaria and geohelminths

Intervention

400 mg albendazole per day orally for three consecutive days in combination with iron supplementation or matching placebo 6 mg/kg body weight for 6 days/week for total duration 8 weeks.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Albendazole, iron supplements

Primary outcome measures

Microscopic and submicroscopic incidence of malaria

Secondary outcome measures

1. Changes in hemoglobin levels
2. Iron parameters (ferritin, sTFR)
3. Endothelial cells markers (ICAM-1 and Vwf)
4. C-reactive protein (CRP)

Overall trial start date

28/07/2011

Overall trial end date

31/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Those who have given informed consent
2. Both males and females
3. Aged between 6-18 years old
4. Malarial parasitemia negative by microscopy
5. Hemoglobin (Hb) > 8 g/dl
6. Hb < 11.5 g/dL for children aged <7 years
7. Hb <12 g/dL for girls aged >= 7 years
8. Hb <13 g/dL for boys aged >=7 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

350

Participant exclusion criteria

Clinical symptoms indicating malaria or any severe underlying condition

Recruitment start date

28/07/2011

Recruitment end date

31/01/2012

Locations

Countries of recruitment

Indonesia

Trial participating centre

Leiden University Medical Center
Leiden
2333 ZA
Netherlands

Sponsor information

Organisation

Nutricia Research Foundation (Netherlands)

Sponsor details

Danone Place Schiphol
P.O. Box 75538
Schiphol-Airport
Amsterdam
1118 ZN
Netherlands

Sponsor type

Research organisation

Website

http://www.nutricia-research-foundation.org

Funders

Funder type

Research organisation

Funder name

Nutricia Research Foundation (Netherlands)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

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

Publication citations

Additional files

Editorial Notes