Improving Iron Status of Children: Potential of Amaranth
2 other identifiers
interventional
270
1 country
1
Brief Summary
Introduction: Iron deficiency anaemia remains a significant public health challenge. Localized food based approaches may offer a large opportunity to improve lives and address the widespread micronutrient deficiencies such as iron in affected households. Viable solutions where iron rich foods are not readily available may come through diversification approaches using foods such as amaranth grain reported to contain high iron content and good quality protein in conjunction with the use of in-home fortification. Objectives: To determine the efficacy of maize porridge enriched with amaranth flour on improving diet quality, iron intake and status in children 12-59 months in a semiarid area in Kenya. Study population: The study population will comprise children aged 12-59 months in Migwani, within the larger Mwingi district, Kenya. Mothers or principal caretakers will be interviewed on behalf of the children. In total, 270 children will be enrolled in the study. Study design: The study has a randomized controlled trial design conducted over a period of 4 months/16 weeks. Treatment/hypothesis: All participating children will be required to take the provided porridge equivalent to 80g of flour 5 days a week for 16 weeks. There will be 3 treatments groups as follows; (1) maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio, (2) maize porridge fortified with a multiple micronutrient powder (MixMe™) and (3) plain maize porridge group. Hypothesis: there will be a significant difference in hemoglobin and iron status between the three groups. Methods: Blood samples (5ml) will be collected by veni-puncture at baseline and after intervention. Hb concentration, Zinc protoporphyrin (ZnPP) and malaria infection will be assessed in the field. Analyses of serum ferritin, serum transferrin receptor and C-reactive protein (CRP) will be done at the participating laboratories. Main study parameter/Endpoints: Change in Hb concentration is the primary outcome of this study. Body iron measured by serum ferritin (SF) and serum transferrin receptor (STfR) are the secondary outcome. Iron deficiency will be defined as SF concentration \<12 µg/L and tissue iron deficiency will be defined as serum transferrin receptor concentration of \>8.3mg/L. Infection will be assessed by raised CRP (\>10mg/L) as an indicator of acute inflammation and presence of malaria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedSeptember 29, 2011
October 1, 2010
8 months
October 18, 2010
September 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin
Hemoglobin (g/l)
Start of study (T=0), End of study (T=4months)
Secondary Outcomes (1)
Iron Status
Begin (t=0), End of study (t=4 months)
Study Arms (3)
Maize porridge with Amaranth
EXPERIMENTALMaize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio (80g/day)
Maize flour with multiple micronutrients
ACTIVE COMPARATORMaize porridge fortified with a multiple micronutrient powder (MixMe™)
Maize Porridge
PLACEBO COMPARATORPlain maize porridge group
Interventions
80g porridge per day, 5 days a week, for 16 weeks (4 months)
Eligibility Criteria
You may qualify if:
- Aged 12-59 months at the time of entry into the study
- Resident in village for at least 6-months and the caretaker plans to remain in the area for the next year
- Apparently healthy at the time of entry into the study
You may not qualify if:
- Severe anaemia i.e. Hb concentration \<70 g/L (See section 5.5)
- Taking iron containing haematinic supplements
- Transfused in the last six months
- Severely undernourished i.e. anthropometric indices \<-3 Z score
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- University of Nairobicollaborator
- Nestlé Foundationcollaborator
- Nevin Scrimshaw International Nutrition Foundationcollaborator
Study Sites (1)
Migwani Area
Migwani Area, Mwingi District, Kenya
Related Publications (2)
Hotz C, Gibson RS. Complementary feeding practices and dietary intakes from complementary foods amongst weanlings in rural Malawi. Eur J Clin Nutr. 2001 Oct;55(10):841-9. doi: 10.1038/sj.ejcn.1601239.
PMID: 11593345BACKGROUNDMacharia-Mutie CW, Moretti D, Van den Briel N, Omusundi AM, Mwangi AM, Kok FJ, Zimmermann MB, Brouwer ID. Maize porridge enriched with a micronutrient powder containing low-dose iron as NaFeEDTA but not amaranth grain flour reduces anemia and iron deficiency in Kenyan preschool children. J Nutr. 2012 Sep;142(9):1756-63. doi: 10.3945/jn.112.157578. Epub 2012 Jul 18.
PMID: 22810982DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 20, 2010
Study Start
October 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
September 29, 2011
Record last verified: 2010-10