A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition (Njugu Plus)

University of Oxford

Status and phase: Completed; Phase 2

Conditions: Severe Acute Malnutrition

Treatments: Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil; Dietary Supplement: Standard RUTF; Dietary Supplement: RUTF/Flax Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT01593969

SSC 2157

OPP1046183 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Standard RUTF

Active Comparator group

Description:

Standard RUTF given according to National Guidelines

Treatment:

Dietary Supplement: Standard RUTF

RUTF/Flax Oil

Experimental group

Description:

RUTF/Flax Oil is reformulated RUTF to increase n3 content

Treatment:

Dietary Supplement: RUTF/Flax Oil

RUTF/Flax Oil plus additional Fish Oil

Experimental group

Description:

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

Treatment:

Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil