A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition (Njugu Plus)
This study is currently recruiting participants.
Verified April 2013 by University of Oxford
Sponsor:
University of Oxford
Collaborator:
KEMRI-Wellcome Trust Collaborative Research Program
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01593969
First received: May 4, 2012
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Acute Malnutrition |
Dietary Supplement: RUTF/Flax Oil Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil Dietary Supplement: Standard RUTF |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition |
Resource links provided by NLM:
MedlinePlus related topics:
Malnutrition
Drug Information available for:
Fish oil
U.S. FDA Resources
Further study details as provided by University of Oxford:
Primary Outcome Measures:
- Total long chain PUFA in erythrocyte membranes at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Total long chain PUFA in erythrocyte membranes at 3 months
Secondary Outcome Measures:
- Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
- Total long chain PUFA in CD3 cell membranes at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Total long chain PUFA in CD3 cell membranes at 3 months
- Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Ratio of n-6:n-3 PUFA in CD3 cell membranes at 3 months
- Total long chain PUFA in plasma at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Total long chain PUFA in plasma at 3 months
- Ratio of n-6:n-3 PUFA in plasma at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Ratio of n-6:n-3 PUFA in plasma at 3 months
- Change in weight for height z score between baseline and 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in weight for height z score between baseline and 3 months
- Change in mid upper arm circumference between baseline and 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change in mid upper arm circumference between baseline and 3 months
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Standard RUTF
Standard RUTF given according to National Guidelines
|
Dietary Supplement: Standard RUTF
Standard formulation RUTF given according to National Guidelines
|
|
Experimental: RUTF/Flax Oil
RUTF/Flax Oil is reformulated RUTF to increase n3 content
|
Dietary Supplement: RUTF/Flax Oil
Ready to Use Therapeutic Food
|
|
Experimental: RUTF/Flax Oil plus additional Fish Oil
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
Ready to Use Therapeutic Food
|
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.
Eligibility| Ages Eligible for Study: | 6 Months to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593969
Contacts
| Contact: James A Berkley, FRCPCH | +254 417 522063 | jberkley@kemri-wellcome.org |
| Contact: Kelsey J Jones, MRCPCH | +254 417 522063 | kjones@kemri-wellcome.org |
Locations
| Kenya | |
| Kilifi District Hospital | Recruiting |
| Kilifi, Coast, Kenya, 80108 | |
| Contact: James A Berkley, MD +254 417 522063 jberkley@kemri-wellcome.org | |
| Contact: Kelsey J Jones, MD +254 417 522063 kjones@kemri-wellcome.org | |
| Principal Investigator: James A Berkley, MD | |
Sponsors and Collaborators
University of Oxford
KEMRI-Wellcome Trust Collaborative Research Program
Investigators
| Principal Investigator: | James A Berkley, FRCPCH | KEMRI-Wellcome Trust Collaborative Research Program |
More Information
No publications provided
| Responsible Party: | University of Oxford |
| ClinicalTrials.gov Identifier: | NCT01593969 History of Changes |
| Other Study ID Numbers: | SSC 2157, OPP1046183 |
| Study First Received: | May 4, 2012 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United Kingdom: Oxford Tropical Research Ethics Committee (OXTREC) Kenya: Ethical Review Committee |
Keywords provided by University of Oxford:
|
Essential Fatty Acid Seed oil Fish oil Dietary deficiency |
Additional relevant MeSH terms:
|
Malnutrition Nutrition Disorders |
ClinicalTrials.gov processed this record on June 18, 2013