AnemiaNCT00628459
Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area
A study testing micronutrient supplementation in people with Anemia and Undernutrition, run by Centre National de la Recherche Scientifique et Technologique at 1 site in Burkina Faso.
Trial summary
Some micronutrients are likely to interact with malaria parasite, leading to either synergistic or antagonist effect on malaria morbidity and therefore on hemoglobin response. The purpose of this study is to investigate the effect of supplementation with iron or multiple micronutrients on anemia while integrated with… Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Anemia, Undernutrition
- What is being tested?
- micronutrient supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Aug 2006to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age of 6-23 months
- hemoglobin concentration range of 70-109 g/L
Who cannot join
- severe wasting (weight-for-height z-score < -3)
Trial locations and contacts
1 site in 1 country.
About this study
Some micronutrients are likely to interact with malaria parasite, leading to either synergistic or antagonist effect on malaria morbidity and therefore on hemoglobin response.
The purpose of this study is to investigate the effect of supplementation with iron or multiple micronutrients on anemia while integrated with malaria management in rural Burkinabe young anemic children with high prevalence of malaria.
Read the detailed description
This is a community-based randomised double-blind trial. Children aged 6-23 months are randomised to receive either iron (n=91), iron and zinc (IZ, n=90) or MMN (n=89), 5 days/week for 6 months. Supplements are manufactured by Nutriset (Malaunay, France) as specifically fortified "plumpy-nut". They are presented in 90 ml boxes coded A, B and C each lot of boxes contained in white packing labelled A, B and C respectively. Malaria is managed in concordance with the national malaria program standards. All mothers receive one insecticide-treated bed-net (PermaNet®, Vestergaard Frandsen Disease Control Textiles) and instruction for effective utilization for children. All children with positive smear for Plasmodium falciparum are artemether+lumefantrine-treated (Coartem®, Novartis Pharma S.A.S., France) regardless of the clinical status. Children aged of at least 12 months receive 200 mg albendazole, one week prior to the supplementation starting.
Data collection involves:
- a questionnaire addressed to mothers at baseline,
- a medical examination of mothers and children at baseline: A general practitioner examines mothers for goiter determination according to the International Council for the Control of Iodine Deficiency Disorders (ICCIDD) definition and classification, and children for splenomegaly that is classified according to Hackett. Anthropometrical measurements are performed on children and mothers by a nutritionist, in agreement with the WHO recommendations. Children's capillary blood is obtained by lab technicians through a finger stick for hemoglobin measurement and malaria blood smear preparation. Hemoglobin is measured using a HemoCue® machine (Hemocue HB 201+, Angelholm, Sweden) to the nearest 1g/L.
- malaria microscopic detection at baseline and monthly during the study: blood smears intending to detect malaria infection are stained with Giemsa, and read in duplicate at the local hospital laboratory,
- a daily record of supplementation and morbidity data (diarrhoea, fever, cough).
The endpoints considered for analysis are change of hemoglobin (final haemoglobin minus baseline haemoglobin concentration) and final anemia status that are analysed by multiple linear regression and logistic regression respectively.
- Conditions
- Anemia, Undernutrition
- Being tested
- micronutrient supplementation
- Keywords
- iron, multiple micronutrient, malaria, anemia, preschool children
- Medical subject headings
- Anemia, Malnutrition, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronutrient supplementationDietary supplement
Supplements are given daily, 5days/week, for 6 months, involving 15 mg iron (arm 1), 15 mg iron and 10 mg zinc (arm 2), or multiple micronutrient (arm 3): 15 mg iron, 10 mg zinc, 375 µg vitamin A, 5 µg vitamin D, 6 mg vitamin E, 0.5 mg vitamin B1, 0.5 mg vitamin B2, 6 mg niacin, 150 µg folic acid, 0.5 mg vitamin B6, 0.9 mg vitamin B12, 35 mg vitamin C, 10 µg vitamin K, 50 µg iodine, 0.6 mg copper.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Dietary Supplement: micronutrient supplementation |
| 2 | Experimental | Not described Receives: Dietary Supplement: micronutrient supplementation |
| 3 | Experimental | Not described Receives: Dietary Supplement: micronutrient supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anemia
Measured: 6 months
Secondary outcomes (1)
Growth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startAug 2006
- Primary completionFeb 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre National de la Recherche Scientifique et Technologique
- Sponsor type
- Other government
- Collaborators
- Université Libre de Bruxelles, Fonds pour la recherche scientifique médicale (FRSM), Belgium
- Investigators
- Philippe Donnen, PhD, Study director, Université Libre de Bruxelles, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628459
- Sponsor's protocol ID
- MIENKO2
- Status last verified
- Feb 2008
- First submitted
- 25 Feb 2008
- Last updated
- 5 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Smuts CM, Dhansay MA, Faber M, van Stuijvenberg ME, Swanevelder S, Gross R, Benade AJ. Efficacy of multiple micronutrient supplementation for improving anemia, micronutrient status, and growth in South African infants. J Nutr. 2005 Mar;135(3):653S-659S. doi: 10.1093/jn/135.3.653S.
PubMed 15735110
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area
- ClinicalTrials.gov ID
- NCT00628459
- Acronym / sponsor ID
- MIENKO2
- Conditions
- Anemia, Undernutrition
- Keywords
- iron, multiple micronutrient, malaria, anemia, preschool children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- Centre National de la Recherche Scientifique et TechnologiqueOther government
- Collaborators
- Université Libre de Bruxelles, Fonds pour la recherche scientifique médicale (FRSM), Belgium
- Study start
- Aug 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some micronutrients are likely to interact with malaria parasite, leading to either synergistic or antagonist effect on malaria morbidity and therefore on hemoglobin response.
The purpose of this study is to investigate the effect of supplementation with iron or multiple micronutrients on anemia while integrated with malaria management in rural Burkinabe young anemic children with high prevalence of malaria.
Detailed description
This is a community-based randomised double-blind trial. Children aged 6-23 months are randomised to receive either iron (n=91), iron and zinc (IZ, n=90) or MMN (n=89), 5 days/week for 6 months. Supplements are manufactured by Nutriset (Malaunay, France) as specifically fortified "plumpy-nut". They are presented in 90 ml boxes coded A, B and C each lot of boxes contained in white packing labelled A, B and C respectively. Malaria is managed in concordance with the national malaria program standards. All mothers receive one insecticide-treated bed-net (PermaNet®, Vestergaard Frandsen Disease Control Textiles) and instruction for effective utilization for children. All children with positive smear for Plasmodium falciparum are artemether+lumefantrine-treated (Coartem®, Novartis Pharma S.A.S., France) regardless of the clinical status. Children aged of at least 12 months receive 200 mg albendazole, one week prior to the supplementation starting.
Data collection involves:
- a questionnaire addressed to mothers at baseline,
- a medical examination of mothers and children at baseline: A general practitioner examines mothers for goiter determination according to the International Council for the Control of Iodine Deficiency Disorders (ICCIDD) definition and classification, and children for splenomegaly that is classified according to Hackett. Anthropometrical measurements are performed on children and mothers by a nutritionist, in agreement with the WHO recommendations. Children's capillary blood is obtained by lab technicians through a finger stick for hemoglobin measurement and malaria blood smear preparation. Hemoglobin is measured using a HemoCue® machine (Hemocue HB 201+, Angelholm, Sweden) to the nearest 1g/L.
- malaria microscopic detection at baseline and monthly during the study: blood smears intending to detect malaria infection are stained with Giemsa, and read in duplicate at the local hospital laboratory,
- a daily record of supplementation and morbidity data (diarrhoea, fever, cough).
The endpoints considered for analysis are change of hemoglobin (final haemoglobin minus baseline haemoglobin concentration) and final anemia status that are analysed by multiple linear regression and logistic regression respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: micronutrient supplementation |
| 2 | Experimental | Dietary Supplement: micronutrient supplementation |
| 3 | Experimental | Dietary Supplement: micronutrient supplementation |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age of 6-23 months
- hemoglobin concentration range of 70-109 g/L
Key exclusion criteria (1 listed)
- severe wasting (weight-for-height z-score < -3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micronutrient supplementationSupplements are given daily, 5days/week, for 6 months, involving 15 mg iron (arm 1), 15 mg iron and 10 mg zinc (arm 2), or multiple micronutrient (arm 3): 15 mg iron, 10 mg zinc, 375 µg vitamin A, 5 µg vitamin D, 6 mg vitamin E, 0.5 mg vitamin B1, 0.5 mg vitamin B2, 6 mg niacin, 150 µg folic acid, 0.5 mg vitamin B6, 0.9 mg vitamin B12, 35 mg vitamin C, 10 µg vitamin K, 50 µg iodine, 0.6 mg copper. | Dietary supplement | 1, 2, 3 |
Primary outcome
Anemia
Time frame: 6 months
1 secondary outcome
Growth
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2008.
- Background: PubMed 15735110Smuts CM, Dhansay MA, Faber M, van Stuijvenberg ME, Swanevelder S, Gross R, Benade AJ. Efficacy of multiple micronutrient supplementation for improving anemia, micronutrient status, and growth in South African infants. J Nutr. 2005 Mar;135(3):653S-659S. doi: 10.1093/jn/135.3.653S.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Donnen, PhD study director
Université Libre de Bruxelles, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micronutrient supplementation in people with Anemia and Undernutrition, run by Centre National de la Recherche Scientifique et Technologique at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anemia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628459, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2008.