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?
July 2011 to 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
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, 08/03/2010, 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 measure
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 (if study stopped)
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
Funders
Funder type
Research organisation
Funder name
Nutricia Research Foundation (Netherlands)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
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
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28129772