Improving Iron Status of Children: Potential of Amaranth
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Anemia Iron Deficiency Anemia |
Dietary Supplement: Maize and Amaranth |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour |
- Hemoglobin [ Time Frame: Start of study (T=0), End of study (T=4months) ] [ Designated as safety issue: No ]Hemoglobin (g/l)
- Iron Status [ Time Frame: Begin (t=0), End of study (t=4 months) ] [ Designated as safety issue: No ]Serum Ferritin microgram/l), serum Transferrin Receptor (mg/l)
| Estimated Enrollment: | 270 |
| Study Start Date: | October 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Maize porridge with Amaranth
Maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio (80g/day)
|
Dietary Supplement: Maize and Amaranth
80g porridge per day, 5 days a week, for 16 weeks (4 months)
Other Name: Mix Me micro-nutrient powder
|
|
Active Comparator: Maize flour with multiple micronutrients
Maize porridge fortified with a multiple micronutrient powder (MixMe™)
|
Dietary Supplement: Maize and Amaranth
80g porridge per day, 5 days a week, for 16 weeks (4 months)
Other Name: Mix Me micro-nutrient powder
|
|
Placebo Comparator: Maize Porridge
Plain maize porridge group
|
Dietary Supplement: Maize and Amaranth
80g porridge per day, 5 days a week, for 16 weeks (4 months)
Other Name: Mix Me micro-nutrient powder
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 12 Months to 59 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wageningen University |
| ClinicalTrials.gov Identifier: | NCT01224535 History of Changes |
| Other Study ID Numbers: | Amaranth, 10/15 |
| Study First Received: | October 18, 2010 |
| Last Updated: | September 28, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Wageningen University:
|
Complementary foods Amaranth Food Based approaches |
Iron Deficiency anemia Arid Areas Africa |
Additional relevant MeSH terms:
|
Anemia Deficiency Diseases Anemia, Iron-Deficiency Hematologic Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic |
Iron Metabolism Disorders Metabolic Diseases Micronutrients Trace Elements Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013