NCT01593969

Brief Summary

The investigators will perform a randomised controlled trial of the provision of food designed for rehabilitation of malnourished children that is supplemented with n-3 fatty acids compared to usual composition. The investigators want to see whether the provision of such a food normalises the deficiencies in essential fatty acids observed in severely malnourished children faster than standard composition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 18, 2014

Status Verified

August 1, 2014

Enrollment Period

1.3 years

First QC Date

May 4, 2012

Last Update Submit

August 15, 2014

Conditions

Severe Acute Malnutrition

Keywords

Essential Fatty AcidSeed oilFish oilDietary deficiency

Outcome Measures

Primary Outcomes (1)

  • Total long chain PUFA in erythrocyte membranes at 3 months

    Total long chain PUFA in erythrocyte membranes at 3 months

    3 months

Secondary Outcomes (7)

  • Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months

    3 months

  • Total long chain PUFA in CD3 cell membranes at 3 months

    3 months

  • Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months

    3 months

  • Total long chain PUFA in plasma at 3 months

    3 months

  • Ratio of n-6:n-3 PUFA in plasma at 3 months

    3 months

  • +2 more secondary outcomes

Study Arms (3)

Standard RUTF

ACTIVE COMPARATOR

Standard RUTF given according to National Guidelines

Dietary Supplement: Standard RUTF

RUTF/Flax Oil

EXPERIMENTAL

RUTF/Flax Oil is reformulated RUTF to increase n3 content

Dietary Supplement: RUTF/Flax Oil

RUTF/Flax Oil plus additional Fish Oil

EXPERIMENTAL

RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3. Fish oil to provide long chain n3

Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil

Interventions

RUTF/Flax OilDIETARY_SUPPLEMENT

Ready to Use Therapeutic Food

RUTF/Flax Oil
RUTF/Flax Oil plus additional Fish OilDIETARY_SUPPLEMENT

Ready to Use Therapeutic Food

RUTF/Flax Oil plus additional Fish Oil
Standard RUTFDIETARY_SUPPLEMENT

Standard formulation RUTF given according to National Guidelines

Standard RUTF

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 months to 5 years old
  • Provision of informed consent
  • Severe malnutrition (one or more of mid-upper arm circumference \<11.5cm, weight for height z score \<-3, or nutritional oedema)
  • Stabilised and eligible to receive RUTF according to national guidelines

You may not qualify if:

  • Known HIV disease, tuberculosis or other chronic infection\*
  • Known allergy or hypersensitivity to any of the product ingredients
  • Chronic infections such as HIV and tuberculosis and their treatments are likely to cause alterations in lipid metabolism that may confound interpretation of this pilot trial. national guidelines recommend offering provider-initiated testing for HIV for all severely malnourished children, and referral for comprehensive care in the case of a positive test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilifi District Hospital

Kilifi, Coast, 80108, Kenya

Location

Related Publications (1)

  • Jones KD, Ali R, Khasira MA, Odera D, West AL, Koster G, Akomo P, Talbert AW, Goss VM, Ngari M, Thitiri J, Ndoro S, Knight MA, Omollo K, Ndungu A, Mulongo MM, Bahwere P, Fegan G, Warner JO, Postle AD, Collins S, Calder PC, Berkley JA. Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial. BMC Med. 2015 Apr 23;13:93. doi: 10.1186/s12916-015-0315-6.

    PMID: 25902844DERIVED

MeSH Terms

Conditions

Severe Acute MalnutritionMalnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • James A Berkley, FRCPCH

    KEMRI-Wellcome Trust Collaborative Research Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 8, 2012

Study Start

May 1, 2012

Primary Completion

August 1, 2013

Study Completion

June 1, 2014

Last Updated

August 18, 2014

Record last verified: 2014-08

Locations

KE(1)