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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Ghent
Sponsor:
Collaborators:
Jimma University
VLIR Institutional University Collaboration Programme
Nutrition Tiers Monde
Nutricia Research Fundation
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01817634
First received: March 20, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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.

Condition Intervention
Child Malnutrition.
Dietary Supplement: Fish powder corn-soy blend'+ Fish oil capsule.
Dietary Supplement: Fish powder corn-soy blend + corn oil capsule.
Dietary Supplement: Corn-soy blend + fish oil capsule.
Dietary Supplement: Corn-soy blend + corn oil capsule.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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.

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Change in length-for-age Z-score over time up to 12 months. [ Time Frame: Every month since baseline until 12 months. ] [ Designated as safety issue: No ]
    Length-for-age Z-score using the WHO 2006 growth reference chart.

  • Development score after study inclusion until 12 months after inclusion. [ Time Frame: 6-monthly since baseline up to 12 months. ] [ Designated as safety issue: No ]
    Development score: Denver II test and Ages-Stages Social-Emotional Questionnaire.


Secondary Outcome Measures:
  • Weight-for-length Z-score up to 12 months. [ Time Frame: 6-monthly up to 12 months. ] [ Designated as safety issue: No ]
    Weight-for-length Z-score: WHO 2006 growth reference chart.

  • Head circumference up to 12 months after inclusion [ Time Frame: Monthly up to 12 months after inclusion ] [ Designated as safety issue: No ]
    Head circumference measurement.

  • Mid-upper arm circumference up to 12 months after inclusion. [ Time Frame: Monthly until 12 months after inclusion. ] [ Designated as safety issue: No ]
    Mid-upper arm circumference.

  • Prevalence of stunting (HAZ <-2- up to 12 months after inclusion. [ Time Frame: 6-monthly until 12 months after inclusion. ] [ Designated as safety issue: No ]
    According to WHO 2006 growth reference chart.

  • Prevalence of wasting (WHZ <-2) until 12 months after inclusion. [ Time Frame: 6-monthly until 12 months after inclusion ] [ Designated as safety issue: No ]
    According to WHO 2006 growth reference chart.

  • C-reactive protein concentration until 12 months after inclusion [ Time Frame: 6-monthly until 12 months after inclusion ] [ Designated as safety issue: No ]
    C-reactive protein concentration.

  • Haemoglobin concentration until 12 months [ Time Frame: 6-monthly until 12 months after inclusion ] [ Designated as safety issue: No ]
    Haemoglobin concentration in blood sample.

  • Infant morbidity at weekly intervals. [ Time Frame: weekly until 12 months after inclusion ] [ Designated as safety issue: No ]
    Infant morbidity (acute respiratory infection, diarrhoea, fever, malaria): weekly recall by caregiver, malaria by microscopy.

  • Breast milk concentrations of DHA/EPA/AA until 12 months after inclusion [ Time Frame: 6-monthly until 12 months after inclusion ] [ Designated as safety issue: No ]
    Breast milk collections to determine milk levels of DHA/EPA/AA.

  • Infant blood concentrations of DHA/EPA/AA until 12 months after inclusion. [ Time Frame: 6-monthly until 12 months after inclusion ] [ Designated as safety issue: No ]
    Blood sample for measuring infant blood levers of DHA/EPA/AA.


Estimated Enrollment: 320
Study Start Date: November 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   6 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01817634

Contacts
Contact: Tefera Belachew, PhD, MD teferabelachew@gmail.com
Contact: Patrick Kolsteren, PhD, MD pkolsteren@itg.be

Locations
Ethiopia
Jimma University Recruiting
Jimma, Ethiopia
Contact: Tefera Belachew, MD, PhD       teferabelachew@gmail.com   
Principal Investigator: Tefera Belachew, MD, PhD         
Sponsors and Collaborators
University Ghent
Jimma University
VLIR Institutional University Collaboration Programme
Nutrition Tiers Monde
Nutricia Research Fundation
Investigators
Principal Investigator: Patrick Kolsteren, MD, PhD University Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01817634     History of Changes
Other Study ID Numbers: 2012/334
Study First Received: March 20, 2013
Last Updated: November 12, 2013
Health Authority: Belgium: Ethics Committee
Ethiopia: Ethical Review Committee
Ethiopia: Food, Medicine and Health Care Administration and Control Authority of Ethiopia

Keywords provided by University Ghent:
Malnutrition.

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 18, 2014