Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia

NCT02479815 | Completed DMC

• 1 other identifier: EPHI_FSNRD_CF_MNP001
• Study Type: interventional
• Target: 2,356
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the safety of iron supplementation in MNPs. A quasi-experimental matched-control cluster design will be used in, purposely selected, 18 intervention and 18 matched-control clusters of Oromia and South Nations Nationalities and People (SNNP) regions of Ethiopia. A total of 2340 infants 6-11 months of age, from intervention and non-intervention clusters will be enrolled and followed longitudinally for 12 months. Morbidity data using standardized questionnaire, will be collected at baseline, and every two weeks for a period of 12 months Research questions to be answered in this study are:

1. 1.Is the provision of low dose iron-containing Micronutrient Powders (MNPs) to young children with or without iron deficiency safe, as assessed by their morbidity from infectious diseases?
2. 2.What is the impact of the provision of low dose iron-containing Micronutrient Powders (MNPs) to young children on (body) iron status? Morbidity data will be collected at baseline, and every two weeks in the same cohort of children.
3. 3.Anthropometry (weight, height, MUAC) every 4 months
4. 4.Breastfeeding status and consumption of processed complementary food portions in the previous week -every 4 months
5. 5.Compliance to study intervention.

Conditions

Nutritional Anemia; Infant Morbidity

Keywords

Complementary feeding recommendation; Program evaluation; Process and impact evaluation; Micronutrient powder (MNP) safety

Outcome Measures

Primary Outcomes (2)

• Anemia

  Hemoglobin \<110g/L

  Baseline and Endline

• % of new acute diarrhea episodes (>3 loose stools/day) per 52 surveillance weeks

  Morbidity from diarrhea (prevalence and incidence rate)

  Up to one year

Secondary Outcomes (4)

• Iron status

  Baseline and Endline

• % of new respiratory infection episodes (cough and/or difficult breathing with or without fever, accompanied by rapid breathing and chest in drawing) per 52 surveillance weeks

  Up to one year

• Prevalence of Fever

  Up to one year

• Growth

  Up to one year

Study Arms (1)

1gm MNP, 15 sachets per month

OTHER

Quasi experimental matched control cluster design where for every child 1gm Micronutrient Powder (MNP) for two days, is given which totlas to 15 sachets per month

Dietary Supplement: Micronutrient Powder (MNP)

Interventions

Micronutrient Powder (MNP) DIETARY_SUPPLEMENT

Every month, 15 MNPs sachets will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification on every alternate day. The MNPs sachets will contain 6 mg Fe together with 14 other vitamins and minerals.

1gm MNP, 15 sachets per month

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Living in one of the selected intervention and non-intervention villages
• Between 6 months and 11.99 months old at the day of recruitment
• Have not yet been provided with MNPs as part of the project interventions
• Free of chronic conditions that may impact their health
• Caregivers do not plan to migrate out of the study area
• Caregivers have provided written informed consent for this additional safety component

You may not qualify if:

• Children who are severely malnourished (Wt/Ht Z-score \< -3 SD) will be referred to treatment and excluded from the safety component
• Children with a chronic disease and/or chronic use of medications
• Children who are severe anemic (Hb\< 70 g/L)

Sponsors & Collaborators

• Ethiopian Public Health Institute: lead
• Micronutrient Initiative: collaborator
• Wageningen University: collaborator

Study Sites (1)

Ethiopian Public Health Institute

Addis Ababa, 1242/5456, Ethiopia

Location

Related Publications (5)

• Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.

  PMID: 10342698 BACKGROUND

• Zimmermann MB, Chassard C, Rohner F, N'goran EK, Nindjin C, Dostal A, Utzinger J, Ghattas H, Lacroix C, Hurrell RF. The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cote d'Ivoire. Am J Clin Nutr. 2010 Dec;92(6):1406-15. doi: 10.3945/ajcn.110.004564. Epub 2010 Oct 20.

  PMID: 20962160 BACKGROUND

• Erhardt JG, Estes JE, Pfeiffer CM, Biesalski HK, Craft NE. Combined measurement of ferritin, soluble transferrin receptor, retinol binding protein, and C-reactive protein by an inexpensive, sensitive, and simple sandwich enzyme-linked immunosorbent assay technique. J Nutr. 2004 Nov;134(11):3127-32. doi: 10.1093/jn/134.11.3127.

  PMID: 15514286 BACKGROUND

• Cook JD, Flowers CH, Skikne BS. The quantitative assessment of body iron. Blood. 2003 May 1;101(9):3359-64. doi: 10.1182/blood-2002-10-3071. Epub 2003 Jan 9.

  PMID: 12521995 BACKGROUND

• Samuel A, Osendarp SJM, Feskens EJM, Lelisa A, Adish A, Kebede A, Brouwer ID. Gender differences in nutritional status and determinants among infants (6-11 m): a cross-sectional study in two regions in Ethiopia. BMC Public Health. 2022 Feb 26;22(1):401. doi: 10.1186/s12889-022-12772-2.

  PMID: 35219315 DERIVED

Related Links

• Sponsor's website

Study Officials

• Saskia JM Osendarp, PhD

  Micronutrient Initiative

  STUDY CHAIR

• Inge D Brouwer, PhD

  Wageningen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 24, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 31, 2018

Record last verified: 2017-02

Locations

ET (1)