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

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ClinicalTrials.gov Identifier: NCT01817634
Recruitment Status : Completed
First Posted : March 25, 2013
Last Update Posted : May 8, 2017
Sponsor:
Collaborators:
Jimma University
VLIR Institutional University Collaboration Programme
Nutrition Tiers Monde
Nutricia Research Fundation
Information provided by (Responsible Party):
University Ghent

Brief Summary:

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 or disease Intervention/treatment
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  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : November 2013
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
U.S. FDA Resources

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817634


Locations
Ethiopia
Jimma University
Jimma, Ethiopia
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

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01817634     History of Changes
Other Study ID Numbers: 2012/334
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by University Ghent:
Malnutrition.

Additional relevant MeSH terms:
Malnutrition
Child Nutrition Disorders
Nutrition Disorders