ω3 LCPUFAs for Healthy Growth and Development of Infants and Young Children in Southwest Ethiopia
Condition: Child Malnutrition
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional

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.
    


Intervention name(s): Fish powder corn-soy blend'+ Fish oil capsule.; Fish powder corn-soy blend + corn oil capsule.; Corn-soy blend + fish oil capsule.; Corn-soy blend + corn oil capsule.
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.; Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.; control food supplement: 0 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.; control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malnutrition.