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Improving Iron Status of Children: Potential of Amaranth

Primary Purpose

Anemia, Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Maize and Amaranth
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Complementary foods, Amaranth, Food Based approaches, Iron Deficiency anemia, Arid Areas, Africa

Eligibility Criteria

12 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Migwani Area

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Maize porridge with Amaranth

Maize flour with multiple micronutrients

Maize Porridge

Arm Description

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

Outcomes

Primary Outcome Measures

Hemoglobin
Hemoglobin (g/l)

Secondary Outcome Measures

Iron Status
Serum Ferritin microgram/l), serum Transferrin Receptor (mg/l)

Full Information

First Posted
October 18, 2010
Last Updated
September 28, 2011
Sponsor
Wageningen University
Collaborators
University of Nairobi, Nestlé Foundation, Nevin Scrimshaw International Nutrition Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01224535
Brief Title
Improving Iron Status of Children: Potential of Amaranth
Official Title
Improving Iron Status of Children in a Semi-arid Area of Kenya: the Potential of Amaranth Grain Flour
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
Collaborators
University of Nairobi, Nestlé Foundation, Nevin Scrimshaw International Nutrition Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background and Rationale The most severe problems of micronutrient deficiency are found amongst resource poor, food insecure and vulnerable households in developing countries. From the 1999 Kenya national survey on micronutrients, it was estimated that seven out of every ten children under five years are likely to be anaemic (Hb<110g/L) and nearly half (43.2%) were iron deficient. The period of complementary feeding is a critical and vulnerable time in the growth and development of children. Poor complementary feeding practices combined with chronic food insecurity are found to substantially contribute to the widespread multiple micronutrients deficiencies in developing countries. A recent food consumption study in Mwingi district in Kenya, showed that ugali (stiff maize porridge) was the primary complementary food. The use of ugali as the primary complementary food suggests that the children may be at risk of inadequate micronutrient intake among children 12-23 months. These findings underscore the need to establish solutions to increase dietary diversity and to promote use of foods that are rich in nutrients such as iron. Amaranth grain offers the prospect of considerably improving dietary food diversification in semi arid areas. Agronomic investigations indicate that amaranth grain contains high iron concentrations ranging from 7.6-27 mg/100g of edible portion. Amaranth grain is a hardy crop and can withstand low rainfall. As such, grain amaranth may offer a viable solution in semi-arid areas where iron rich foods such as animal and fortified products are not readily available. This study has therefore been designed to investigate the efficacy of porridge made from amaranth enriched maize flour in improving the diet quality and iron intake in children 12-59 months in a semi-arid area in Kenya. Home fortification of complementary foods using micronutrient powders has also been shown to reduce iron deficiency anaemia in many resource-poor settings including Kenya. Objectives The primary objective of this study is To determine the efficacy of maize porridge enriched with amaranth grain flour on improving iron intake and status in children 12-59 months in a semi arid area in Kenya. In addition we aim: To determine the efficacy of amaranth grain enriched maize porridge compared to maize porridge fortified with micronutrient multi-mix powder (MixMe™) to improve iron status and intake of children 12-59 months. To determine the iron, zinc and nutritional status of children 12-59 months. Hypothesis We hypothesize that: Children receiving amaranth grain enriched maize porridge will show greater improvement in iron status than those receiving plain maize porridge. Children receiving amaranth enriched maize porridge will show less improvement in iron status than those receiving maize porridge fortified with micronutrient multi-mix powder (MixMe™). Study Area and Population The study will be conducted in Migwani within the larger Mwingi District in Eastern Kenya. This area falls within the arid and semi arid area (ASAL) and thus experiences food shortage for most part of the year. The study population will comprise children aged 12-59 months. Mothers or principal caretakers will be interviewed on behalf of the children. Study Design The study will have a randomized controlled trial design conducted over a period of 4 months/16 weeks. The administrative study area has been purposively selected as it falls within an agro-ecological zone of a semi-arid area. Random sampling out of a total of six Sub-locations in Migwani will be done to get 4 Sub-locations. Within a Sub-location, individual sampling units (Household with a child aged 12-59 months) will be selected using a random walk method until the required sample size of 68 children is achieved per Sub-location. Children who meet the inclusion criteria shall be randomly assigned to one of the following treatment groups: Maize porridge enriched with amaranth grain flour Maize porridge fortified with a multiple micronutrient powder (MixMe™) Plain maize porridge

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency Anemia
Keywords
Complementary foods, Amaranth, Food Based approaches, Iron Deficiency anemia, Arid Areas, Africa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maize porridge with Amaranth
Arm Type
Experimental
Arm Description
Maize porridge enriched with amaranth grain flour at 70:30 maize/amaranth ratio (80g/day)
Arm Title
Maize flour with multiple micronutrients
Arm Type
Active Comparator
Arm Description
Maize porridge fortified with a multiple micronutrient powder (MixMe™)
Arm Title
Maize Porridge
Arm Type
Placebo Comparator
Arm Description
Plain maize porridge group
Intervention Type
Dietary Supplement
Intervention Name(s)
Maize and Amaranth
Other Intervention Name(s)
Mix Me micro-nutrient powder
Intervention Description
80g porridge per day, 5 days a week, for 16 weeks (4 months)
Primary Outcome Measure Information:
Title
Hemoglobin
Description
Hemoglobin (g/l)
Time Frame
Start of study (T=0), End of study (T=4months)
Secondary Outcome Measure Information:
Title
Iron Status
Description
Serum Ferritin microgram/l), serum Transferrin Receptor (mg/l)
Time Frame
Begin (t=0), End of study (t=4 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Migwani Area
City
Migwani Area
State/Province
Mwingi District
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
11593345
Citation
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.
Results Reference
background
PubMed Identifier
22810982
Citation
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.
Results Reference
derived

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Improving Iron Status of Children: Potential of Amaranth

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