ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia (OME³Jim)

May 3, 2017 updated by: University Ghent

ω3 Long-chain Polyunsaturated Fatty Acids for Healthy Growth and Development of Infants and Young Children in the Gilgel Gibe Hydroelectric Dam Area, Ethiopia.

New approaches are needed to prevent growth failure in children from low- and middle-income countries (LMIC). To date, nutrition intervention studies have focused on micronutrient and energy content of complementary foods and have yielded only small to moderate effects on growth and development. There appears to be a missing link that mediates and reduces the expected beneficial effect. Child populations in LMIC show an asymptomatic environmental enteropathy that is characterized by a reduced size of the small intestinal villi, decreased gut integrity and a chronic inflammatory response in the gut. Results from studies in industrialized countries suggest that ω3 long-chain polyunsaturated fatty acids (ω3 LCPUFAs) improve immune response and gut integrity. These reported beneficial effects could result in even more important physiological implications for children from LMIC and will ultimately contribute to their healthy growth and development.

The hypothesis of the OME³Jim study is that an increased intake of ω3 LCPUFAs through complementary foods and human milk has an effect on infant growth and development in a context of high malnutrition rates and low ω3 LCPUFAs intake. This study will identify whether intake by either or both mother and infant is more effective.

The specific objectives of the OME³Jim study are:

  1. To test the effect of supplementing infants with an ω3 LCPUFAs fortified food supplement on infant growth, morbidity, nutritional status and development;
  2. To test the effect of supplementing lactating mothers with an ω3 LCPUFAs oil capsule on infant growth, nutritional status and development;
  3. To test the combined effect (dose response) of supplementing ω3 LCPUFAs to lactating mothers and infant on infant growth, morbidity, nutritional status and development:
  4. To test the effect of ω3 LCPUFAs supplementation on ω3 LCPUFA status in infants and human milk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Jimma, Ethiopia
        • Jimma University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Singleton infants
  • 6-12 months old
  • Not suffering from acute malnutrition (wasting): WHZ > -2 , no edema
  • Infants currently being breastfed
  • Anticipated local residence for the study duration
  • Not planning to leave the study area for more than 1 month

Exclusion Criteria:

  • Current supplement use or medical treatment of infant and/or mother
  • Infants developing severe anemia (<70 g/L) or edema are referred to the nearby health institution for evaluation and treatment, and are omitted from the trial
  • Presence of congenital abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Food supplement Intervention - Capsule Intervention
Omega 3 food supplement + Omega 3 capsule.
Dietary supplement: Fish powder corn-soy blend'+ Fish oil capsule.
Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
EXPERIMENTAL: Food Supplement Intervention - Capsule Control
Omega 3 food supplement + Control Capsule.
Dietary supplement: Fish powder corn-soy blend + corn oil capsule.
Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.
EXPERIMENTAL: Food Supplement Control - Capusle Intervention
Food supplement control + Omega 3 Capsule.
Dietary supplement: Corn-soy blend + fish oil capsule.
control food supplement: 0 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
ACTIVE_COMPARATOR: Food Supplement Control - Capsule Control
Food supplement control + Control Capsule.
Dietary supplement: Corn-soy blend + corn oil capsule.
control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in length-for-age Z-score over time up to 12 months.
Time Frame: Every month since baseline until 12 months.
Length-for-age Z-score using the WHO 2006 growth reference chart.
Every month since baseline until 12 months.
Development score after study inclusion until 12 months after inclusion.
Time Frame: 6-monthly since baseline up to 12 months.
Development score: Denver II test and Ages-Stages Social-Emotional Questionnaire.
6-monthly since baseline up to 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight-for-length Z-score up to 12 months.
Time Frame: 6-monthly up to 12 months.
Weight-for-length Z-score: WHO 2006 growth reference chart.
6-monthly up to 12 months.
Head circumference up to 12 months after inclusion
Time Frame: Monthly up to 12 months after inclusion
Head circumference measurement.
Monthly up to 12 months after inclusion
Mid-upper arm circumference up to 12 months after inclusion.
Time Frame: Monthly until 12 months after inclusion.
Mid-upper arm circumference.
Monthly until 12 months after inclusion.
Prevalence of stunting (HAZ <-2- up to 12 months after inclusion.
Time Frame: 6-monthly until 12 months after inclusion.
According to WHO 2006 growth reference chart.
6-monthly until 12 months after inclusion.
Prevalence of wasting (WHZ <-2) until 12 months after inclusion.
Time Frame: 6-monthly until 12 months after inclusion
According to WHO 2006 growth reference chart.
6-monthly until 12 months after inclusion
C-reactive protein concentration until 12 months after inclusion
Time Frame: 6-monthly until 12 months after inclusion
C-reactive protein concentration.
6-monthly until 12 months after inclusion
Haemoglobin concentration until 12 months
Time Frame: 6-monthly until 12 months after inclusion
Haemoglobin concentration in blood sample.
6-monthly until 12 months after inclusion
Infant morbidity at weekly intervals.
Time Frame: weekly until 12 months after inclusion
Infant morbidity (acute respiratory infection, diarrhoea, fever, malaria): weekly recall by caregiver, malaria by microscopy.
weekly until 12 months after inclusion
Breast milk concentrations of DHA/EPA/AA until 12 months after inclusion
Time Frame: 6-monthly until 12 months after inclusion
Breast milk collections to determine milk levels of DHA/EPA/AA.
6-monthly until 12 months after inclusion
Infant blood concentrations of DHA/EPA/AA until 12 months after inclusion.
Time Frame: 6-monthly until 12 months after inclusion
Blood sample for measuring infant blood levers of DHA/EPA/AA.
6-monthly until 12 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

Jimma University
Nutricia Research Fundation
VLIR Institutional University Collaboration Programme
Nutrition Tiers Monde

Investigators

  • Principal Investigator: Patrick Kolsteren, MD, PhD, University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 22, 2013

First Posted (ESTIMATE)

March 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/334

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child Malnutrition

Clinical Trials on Fish powder corn-soy blend'+ Fish oil capsule.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe