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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01593969
Other study ID # SSC 2157
Secondary ID OPP1046183
Status Completed
Phase Phase 2
First received May 4, 2012
Last updated August 15, 2014
Start date May 2012
Est. completion date June 2014

Study information

Verified date August 2014
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Oxford Tropical Research Ethics Committee (OXTREC)Kenya: Ethical Review Committee
Study type Interventional

Clinical Trial 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.


Description:

Randomized controlled trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Severe Malnutrition.

Description of Study Design: Randomized Controlled Trial

Study Duration: 6 months (Trial); 12 months (All trial-related activities)

Description of Intervention: Provision of ready to use food (RUTF) enriched with flax seed oil, with or without fish oil, compared to conventional-composition RUTF. Interventional product will be given until nutritional recovery to a maximum of 12 weeks.

Design: Flax-enriched or standard RUTF allocation is randomised and double blind. Fish oil allocation is randomised within those receiving flax-enriched RUTF and is open label.

Location: Kilifi District, coastal Kenya.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 2014
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 5 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
RUTF/Flax Oil
Ready to Use Therapeutic Food
RUTF/Flax Oil plus additional Fish Oil
Ready to Use Therapeutic Food
Standard RUTF
Standard formulation RUTF given according to National Guidelines

Locations

Country Name City State
Kenya Kilifi District Hospital Kilifi Coast

Sponsors (2)

Lead Sponsor Collaborator
University of Oxford KEMRI-Wellcome Trust Collaborative Research Program

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total long chain PUFA in erythrocyte membranes at 3 months Total long chain PUFA in erythrocyte membranes at 3 months 3 months No
Secondary Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months 3 months No
Secondary Total long chain PUFA in CD3 cell membranes at 3 months Total long chain PUFA in CD3 cell membranes at 3 months 3 months No
Secondary Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months 3 months No
Secondary Total long chain PUFA in plasma at 3 months Total long chain PUFA in plasma at 3 months 3 months No
Secondary Ratio of n-6:n-3 PUFA in plasma at 3 months Ratio of n-6:n-3 PUFA in plasma at 3 months 3 months No
Secondary Change in weight for height z score between baseline and 3 months Change in weight for height z score between baseline and 3 months 3 months No
Secondary Change in mid upper arm circumference between baseline and 3 months Change in mid upper arm circumference between baseline and 3 months 3 months No
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