Clinical Trial: ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

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 (do

    Detailed Summary:
    Sponsor: University Ghent

    Current Primary Outcome:

    • 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.
    • 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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.
    • Head circumference up to 12 months after inclusion [ Time Frame: Monthly up to 12 months after inclusion ]
      Head circumference measurement.
    • Mid-upper arm circumference up to 12 months after inclusion. [ Time Frame: Monthly until 12 months after inclusion. ]
      Mid-upper arm circumference.
    • 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.
    • 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.
    • C-reactive protein concentration until 12 months after inclusion [ Time Frame: 6-monthly until 12 months after inclusion ]
      C-reactive protein concentration.
    • Haemoglobin concentration until 12 months [ Time Frame: 6-monthly until 12 months after inclusion ]
      Haemoglobin concentration in blood sample.
    • 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.
    • 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.
    • 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.


    Original Secondary Outcome: Same as current

    Information By: University Ghent

    Dates:
    Date Received: March 20, 2013
    Date Started: November 2013
    Date Completion:
    Last Updated: May 3, 2017
    Last Verified: May 2017