NCT01593969

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

A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Severe Acute Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	RUTF/Flax Oil	Ready to Use Therapeutic Food
DIETARY_SUPPLEMENT	RUTF/Flax Oil plus additional Fish Oil	Ready to Use Therapeutic Food
DIETARY_SUPPLEMENT	Standard RUTF	Standard formulation RUTF given according to National Guidelines

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-08-01
• Completion: 2014-06-01
• First posted: 2012-05-08
• Last updated: 2014-08-18

Locations

1 site across 1 country: Kenya