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

NCT01817634 | Completed

• 1 other identifier: 2012/334
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 1

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. 1.To test the effect of supplementing infants with an ω3 LCPUFAs fortified food supplement on infant growth, morbidity, nutritional status and development;
2. 2.To test the effect of supplementing lactating mothers with an ω3 LCPUFAs oil capsule on infant growth, nutritional status and development;
3. 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. 4.To test the effect of ω3 LCPUFAs supplementation on ω3 LCPUFA status in infants and human milk.

Conditions

Child Malnutrition

Keywords

Malnutrition.

Outcome Measures

Primary Outcomes (2)

• Change in length-for-age Z-score over time up to 12 months.

  Length-for-age Z-score using the WHO 2006 growth reference chart.

  Every month since baseline until 12 months.

• Development score after study inclusion until 12 months after inclusion.

  Development score: Denver II test and Ages-Stages Social-Emotional Questionnaire.

  6-monthly since baseline up to 12 months.

Secondary Outcomes (10)

• Weight-for-length Z-score up to 12 months.

  6-monthly up to 12 months.

• Head circumference up to 12 months after inclusion

  Monthly up to 12 months after inclusion

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

  Monthly until 12 months after inclusion.

• Prevalence of stunting (HAZ <-2- up to 12 months after inclusion.

  6-monthly until 12 months after inclusion.

• Prevalence of wasting (WHZ <-2) until 12 months after inclusion.

  6-monthly until 12 months after inclusion

Study Arms (4)

Food supplement Intervention - Capsule Intervention

EXPERIMENTAL

Omega 3 food supplement + Omega 3 capsule.

Dietary Supplement: Fish powder corn-soy blend'+ Fish oil capsule.

Food Supplement Intervention - Capsule Control

EXPERIMENTAL

Omega 3 food supplement + Control Capsule.

Dietary Supplement: Fish powder corn-soy blend + corn oil capsule.

Food Supplement Control - Capusle Intervention

EXPERIMENTAL

Food supplement control + Omega 3 Capsule.

Dietary Supplement: Corn-soy blend + fish oil capsule.

Food Supplement Control - Capsule Control

ACTIVE COMPARATOR

Food supplement control + Control Capsule.

Dietary Supplement: Corn-soy blend + corn oil capsule.

Interventions

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.

Food supplement Intervention - Capsule Intervention

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.

Food Supplement Intervention - Capsule Control

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.

Food Supplement Control - Capusle Intervention

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.

Food Supplement Control - Capsule Control

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Singleton infants
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• Jimma University: collaborator
• VLIR Institutional University Collaboration Programme: collaborator
• Nutrition Tiers Monde: collaborator
• Nutricia Research Fundation: collaborator

Study Sites (1)

Jimma University

Jimma, Ethiopia

Location

Related Publications (3)

• Argaw A, Bouckaert KP, Wondafrash M, Kolsteren P, Lachat C, De Meulenaer B, Hanley-Cook G, Huybregts L. Effect of fish-oil supplementation on breastmilk long-chain polyunsaturated fatty acid concentration: a randomized controlled trial in rural Ethiopia. Eur J Clin Nutr. 2021 May;75(5):809-816. doi: 10.1038/s41430-020-00798-x. Epub 2020 Nov 6.

  PMID: 33159163 DERIVED

• Argaw A, Huybregts L, Wondafrash M, Kolsteren P, Belachew T, Worku BN, Abessa TG, Bouckaert KP. Neither n-3 Long-Chain PUFA Supplementation of Mothers through Lactation nor of Offspring in a Complementary Food Affects Child Overall or Social-Emotional Development: A 2 x 2 Factorial Randomized Controlled Trial in Rural Ethiopia. J Nutr. 2019 Mar 1;149(3):505-512. doi: 10.1093/jn/nxy202.

  PMID: 30544211 DERIVED

• Argaw A, Wondafrash M, Bouckaert KP, Kolsteren P, Lachat C, Belachew T, De Meulenaer B, Huybregts L. Effects of n-3 long-chain PUFA supplementation to lactating mothers and their breastfed children on child growth and morbidity: a 2 x 2 factorial randomized controlled trial in rural Ethiopia. Am J Clin Nutr. 2018 Mar 1;107(3):454-464. doi: 10.1093/ajcn/nqx057.

  PMID: 29566189 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition

Interventions

Corn Oil; Fish Oils

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Patrick Kolsteren, MD, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 25, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

ET (1)