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Sponsor study identifier
Secondary identifiers
OTHER · Wageningen University Ethical Comitee
interventional
270
1 country
1
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2011
Actual (reported)Study Completion
June 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 18, 2010
Actual (reported)October 20, 2010
Actual (reported)June 2011
Actual (reported)June 2011
Actual (reported)Hemoglobin
Hemoglobin (g/l)
Start of study (T=0), End of study (T=4months)
Iron Status
Begin (t=0), End of study (t=4 months)
Maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio (80g/day)
Maize porridge fortified with a multiple micronutrient powder (MixMe™)
Plain maize porridge group
80g porridge per day, 5 days a week, for 16 weeks (4 months)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Migwani Area
Migwani Area, Mwingi District, Kenya
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.
Macharia-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.
First Submitted
October 18, 2010
First Posted
October 20, 2010
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2011
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
June 2011
Actual (reported)Last Updated
September 29, 2011
Record last verified: 2010-10
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Source: ClinicalTrials.gov.
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