AzTrials
AzTrials

Child MalnutritionOME³JimNCT01817634

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

A study testing Fish powder corn-soy blend'+ Fish oil capsule., Fish powder corn-soy blend + corn oil capsule. and Corn-soy blend + fish oil capsule. in people with Child Malnutrition, run by University Ghent at 1 site in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 monthsHealthy volunteers can take part
Conditions the study is for
Child Malnutrition
What is being tested?
Fish powder corn-soy blend'+ Fish oil capsule., Fish powder corn-soy blend + corn oil capsule. and Corn-soy blend + fish oil capsule.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
1 siteEthiopia
Study dates
Nov 2013to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ethiopia1 site

  • Jimma University

    Jimma

Other trials in Ethiopia

About this study

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.

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.

Read more

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.
Being tested
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.
Keywords
Malnutrition.
Medical subject headings
Child Nutrition Disorders, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

  • 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.

Study groups in NCT01817634
Study groupRoleWhat they receive
Food supplement Intervention - Capsule InterventionExperimentalOmega 3 food supplement + Omega 3 capsule.
Receives: Dietary Supplement: Fish powder corn-soy blend'+ Fish oil capsule.
Food Supplement Intervention - Capsule ControlExperimentalOmega 3 food supplement + Control Capsule.
Receives: Dietary Supplement: Fish powder corn-soy blend + corn oil capsule.
Food Supplement Control - Capusle InterventionExperimentalFood supplement control + Omega 3 Capsule.
Receives: Dietary Supplement: Corn-soy blend + fish oil capsule.
Food Supplement Control - Capsule ControlActive comparatorFood supplement control + Control Capsule.
Receives: Dietary Supplement: Corn-soy blend + corn oil capsule.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Every month since baseline until 12 months.

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

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

    Measured: 6-monthly since baseline up to 12 months.

Secondary outcomes (10)

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

    Weight-for-length Z-score: WHO 2006 growth reference chart.

    Measured: 6-monthly up to 12 months.

  2. Head circumference up to 12 months after inclusion

    Head circumference measurement.

    Measured: Monthly up to 12 months after inclusion

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

    Mid-upper arm circumference.

    Measured: Monthly until 12 months after inclusion.

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

    According to WHO 2006 growth reference chart.

    Measured: 6-monthly until 12 months after inclusion.

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

    According to WHO 2006 growth reference chart.

    Measured: 6-monthly until 12 months after inclusion

  6. C-reactive protein concentration until 12 months after inclusion

    C-reactive protein concentration.

    Measured: 6-monthly until 12 months after inclusion

  7. Haemoglobin concentration until 12 months

    Haemoglobin concentration in blood sample.

    Measured: 6-monthly until 12 months after inclusion

  8. Infant morbidity at weekly intervals.

    Infant morbidity (acute respiratory infection, diarrhoea, fever, malaria): weekly recall by caregiver, malaria by microscopy.

    Measured: weekly until 12 months after inclusion

  9. Breast milk concentrations of DHA/EPA/AA until 12 months after inclusion

    Breast milk collections to determine milk levels of DHA/EPA/AA.

    Measured: 6-monthly until 12 months after inclusion

  10. Infant blood concentrations of DHA/EPA/AA until 12 months after inclusion.

    Blood sample for measuring infant blood levers of DHA/EPA/AA.

    Measured: 6-monthly until 12 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01817634
Sponsor's protocol ID
2012/334
Acronym
OME³Jim
Status last verified
May 2017
First submitted
20 Mar 2013
Last updated
8 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 33159163

  • 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.

    PubMed 30544211

  • 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.

    PubMed 29566189

Questions about this trial

What is this clinical trial studying?

A study testing Fish powder corn-soy blend'+ Fish oil capsule., Fish powder corn-soy blend + corn oil capsule. and Corn-soy blend + fish oil capsule. in people with Child Malnutrition, run by University Ghent at 1 site in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in length-for-age Z-score over time up to 12 months. (time frame: Every month since baseline until 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01817634, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in