A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition (Njugu Plus)
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ClinicalTrials.gov Identifier: NCT01593969 |
Recruitment Status :
Completed
First Posted : May 8, 2012
Last Update Posted : August 18, 2014
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Condition or disease | Intervention/treatment | Phase |
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Severe Acute Malnutrition | Dietary Supplement: RUTF/Flax Oil Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil Dietary Supplement: Standard RUTF | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Standard RUTF
Standard RUTF given according to National Guidelines
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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
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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
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Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil
Ready to Use Therapeutic Food |
- Total long chain PUFA in erythrocyte membranes at 3 months [ Time Frame: 3 months ]Total long chain PUFA in erythrocyte membranes at 3 months
- Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months [ Time Frame: 3 months ]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 ]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 ]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 ]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 ]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 ]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 ]Change in mid upper arm circumference between baseline and 3 months

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Ages Eligible for Study: | 6 Months to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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*
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593969
Kenya | |
Kilifi District Hospital | |
Kilifi, Coast, Kenya, 80108 |
Principal Investigator: | James A Berkley, FRCPCH | KEMRI-Wellcome Trust Collaborative Research Program |
Responsible Party: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT01593969 |
Other Study ID Numbers: |
SSC 2157 OPP1046183 ( Other Grant/Funding Number: The Bill & Melinda Gates Foundation ) |
First Posted: | May 8, 2012 Key Record Dates |
Last Update Posted: | August 18, 2014 |
Last Verified: | August 2014 |
Essential Fatty Acid Seed oil Fish oil Dietary deficiency |
Malnutrition Severe Acute Malnutrition Nutrition Disorders |