Safe and effective iron supplementation in malaria endemic areas
| ISRCTN | ISRCTN83091970 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83091970 |
| Secondary identifying numbers | 2010-26 |
- Submission date
- 10/04/2012
- Registration date
- 16/05/2012
- Last edited
- 30/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
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
Contact information
Scientific
Department of Parasitology
Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Study information
| Study design | Randomized placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Towards safe and effective iron supplementation in malaria endemic areas: randomized double-blind placebo controlled trial |
| Study objectives | Iron supplementation in anemic subjects with submicroscopic malaria increases hemoglobin levels but does not increase parasitaemia. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 28/07/2011 |
| Completion date | 31/01/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 350 |
| Key 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 |
| Key exclusion criteria | Clinical symptoms indicating malaria or any severe underlying condition |
| Date of first enrolment | 28/07/2011 |
| Date of final enrolment | 31/01/2012 |
Locations
Countries of recruitment
- Indonesia
- Netherlands
Study participating centre
2333 ZA
Netherlands
Sponsor information
Research organisation
Danone Place Schiphol
P.O. Box 75538
Schiphol-Airport
Amsterdam
1118 ZN
Netherlands
| Website | http://www.nutricia-research-foundation.org |
|---|---|
"ROR" |
https://ror.org/00vt3ry76 |
Funders
Funder type
Research organisation
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Netherlands
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 | 28/01/2017 | Yes | No |
Editorial Notes
30/01/2017: Publication reference added.
