Severe Acute MalnutritionPhase 2Njugu PlusNCT01593969
A Trial of n-3 PUFA-Enriched Ready to Use Therapeutic Food for Childhood Severe Malnutrition
A Phase 2 study testing RUTF/Flax Oil, RUTF/Flax Oil plus additional Fish Oil and Standard RUTF in people with Severe Acute Malnutrition, run by University of Oxford at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- RUTF/Flax Oil, RUTF/Flax Oil plus additional Fish Oil and Standard RUTF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKenya
- Study dates
- May 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
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.
Read the 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
- Being tested
- RUTF/Flax Oil, RUTF/Flax Oil plus additional Fish Oil, Standard RUTF
- Keywords
- Essential Fatty Acid, Seed oil, Fish oil, Dietary deficiency
- Medical subject headings
- Severe Acute Malnutrition, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUTF/Flax OilDietary supplement
Ready to Use Therapeutic Food
RUTF/Flax Oil plus additional Fish OilDietary supplement
Ready to Use Therapeutic Food
Standard RUTFDietary supplement
Standard formulation RUTF given according to National Guidelines
| Study group | Role | What they receive |
|---|---|---|
| Standard RUTF | Active comparator | Standard RUTF given according to National Guidelines Receives: Dietary Supplement: Standard RUTF |
| RUTF/Flax Oil | Experimental | RUTF/Flax Oil is reformulated RUTF to increase n3 content Receives: Dietary Supplement: RUTF/Flax Oil |
| RUTF/Flax Oil plus additional Fish Oil | Experimental | RUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3. Fish oil to provide long chain n3 Receives: Dietary Supplement: RUTF/Flax Oil plus additional Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total long chain PUFA in erythrocyte membranes at 3 months
Total long chain PUFA in erythrocyte membranes at 3 months
Measured: 3 months
Secondary outcomes (7)
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
Measured: 3 months
Total long chain PUFA in CD3 cell membranes at 3 months
Total long chain PUFA in CD3 cell membranes at 3 months
Measured: 3 months
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
Measured: 3 months
Total long chain PUFA in plasma at 3 months
Total long chain PUFA in plasma at 3 months
Measured: 3 months
Ratio of n-6:n-3 PUFA in plasma at 3 months
Ratio of n-6:n-3 PUFA in plasma at 3 months
Measured: 3 months
Change in weight for height z score between baseline and 3 months
Change in weight for height z score between baseline and 3 months
Measured: 3 months
Change in mid upper arm circumference between baseline and 3 months
Change in mid upper arm circumference between baseline and 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- KEMRI-Wellcome Trust Collaborative Research Program
- Responsible party
- Sponsor
- Investigators
- James A Berkley, FRCPCH, Principal investigator, KEMRI-Wellcome Trust Collaborative Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593969
- Sponsor's protocol ID
- SSC 2157
- Other IDs
- OPP1046183
- Acronym
- Njugu Plus
- Status last verified
- Aug 2014
- First submitted
- 4 May 2012
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones KD, Ali R, Khasira MA, Odera D, West AL, Koster G, Akomo P, Talbert AW, Goss VM, Ngari M, Thitiri J, Ndoro S, Knight MA, Omollo K, Ndungu A, Mulongo MM, Bahwere P, Fegan G, Warner JO, Postle AD, Collins S, Calder PC, Berkley JA. Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial. BMC Med. 2015 Apr 23;13:93. doi: 10.1186/s12916-015-0315-6.
PubMed 25902844
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of n-3 Polyunsaturated Fatty Acid-Enriched Therapeutic Food for Childhood Severe Malnutrition
- ClinicalTrials.gov ID
- NCT01593969
- Acronym / sponsor ID
- Njugu Plus / SSC 2157
- Conditions
- Severe Acute Malnutrition
- Keywords
- Essential Fatty Acid, Seed oil, Fish oil, Dietary deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- KEMRI-Wellcome Trust Collaborative Research Program
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard RUTF | Active comparator | Dietary Supplement: Standard RUTFStandard RUTF given according to National Guidelines |
| RUTF/Flax Oil | Experimental | Dietary Supplement: RUTF/Flax OilRUTF/Flax Oil is reformulated RUTF to increase n3 content |
| RUTF/Flax Oil plus additional Fish Oil | Experimental | Dietary Supplement: RUTF/Flax Oil plus additional Fish OilRUTF/Flax Oil plus additional Fish Oil is RUTF reformulated to increase n3. Fish oil to provide long chain n3 |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Known HIV disease, tuberculosis or other chronic infection*
- Known allergy or hypersensitivity to any of the product ingredients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUTF/Flax OilReady to Use Therapeutic Food | Dietary supplement | RUTF/Flax Oil |
| RUTF/Flax Oil plus additional Fish OilReady to Use Therapeutic Food | Dietary supplement | RUTF/Flax Oil plus additional Fish Oil |
| Standard RUTFStandard formulation RUTF given according to National Guidelines | Dietary supplement | Standard RUTF |
Primary outcome
Total long chain PUFA in erythrocyte membranes at 3 months
Time frame: 3 months
Total long chain PUFA in erythrocyte membranes at 3 months
7 secondary outcomes
Ratio of n-6:n-3 PUFA in erythrocyte membranes at 3 months
Time frame: 3 months
Total long chain 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
Time frame: 3 months
Total long chain PUFA in plasma at 3 months
Time frame: 3 months
Ratio of n-6:n-3 PUFA in plasma at 3 months
Time frame: 3 months
Change in weight for height z score between baseline and 3 months
Time frame: 3 months
Change in mid upper arm circumference between baseline and 3 months
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Derived from this study: PubMed 25902844Jones KD, Ali R, Khasira MA, Odera D, West AL, Koster G, Akomo P, Talbert AW, Goss VM, Ngari M, Thitiri J, Ndoro S, Knight MA, Omollo K, Ndungu A, Mulongo MM, Bahwere P, Fegan G, Warner JO, Postle AD, Collins S, Calder PC, Berkley JA. Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial. BMC Med. 2015 Apr 23;13:93. doi: 10.1186/s12916-015-0315-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Berkley, FRCPCH principal investigator
KEMRI-Wellcome Trust Collaborative Research Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RUTF/Flax Oil, RUTF/Flax Oil plus additional Fish Oil and Standard RUTF in people with Severe Acute Malnutrition, run by University of Oxford at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total long chain PUFA in erythrocyte membranes at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01593969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014.