Improving Iron Status of Children: Potential of Amaranth

This study has been completed.
Sponsor:
Collaborators:
University of Nairobi
Nestlé Foundation
International Nutrition Foundation (INF)
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01224535
First received: October 18, 2010
Last updated: September 28, 2011
Last verified: October 2010
  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

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Hemoglobin [ Time Frame: Start of study (T=0), End of study (T=4months) ] [ Designated as safety issue: No ]
    Hemoglobin (g/l)


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224535

Locations
Kenya
Migwani Area
Migwani Area, Mwingi District, Kenya
Sponsors and Collaborators
Wageningen University
University of Nairobi
Nestlé Foundation
International Nutrition Foundation (INF)
  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 August 28, 2014