Skip to main content
OpenTrials
Completed

NCT Number: NCT01817634

ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jimma University

Jimma, Ethiopia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fish powder corn-soy blend'+ Fish oil capsule.

Dietary Supplement

Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.

Fish powder corn-soy blend + corn oil capsule.

Dietary Supplement

Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.

Corn-soy blend + fish oil capsule.

Dietary Supplement

control food supplement: 0 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.

Corn-soy blend + corn oil capsule.

Dietary Supplement

control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. Head circumference up to 12 months after inclusion

    Time frame: Monthly up to 12 months after inclusion

    Head circumference measurement.

  3. Mid-upper arm circumference up to 12 months after inclusion.

    Time frame: Monthly until 12 months after inclusion.

    Mid-upper arm circumference.

  4. 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.

  5. 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. C-reactive protein concentration until 12 months after inclusion

    Time frame: 6-monthly until 12 months after inclusion

    C-reactive protein concentration.

  7. Haemoglobin concentration until 12 months

    Time frame: 6-monthly until 12 months after inclusion

    Haemoglobin concentration in blood sample.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

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

Registry information

Official study title

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

Acronym: OME³Jim

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2013
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.