MalnutritionFLNS_SAMNCT02907424
Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM
A study testing 2 months of treatment in people with Malnutrition and Children, run by Institut de Recherche pour le Developpement at 1 site in Cambodia.
Trial summary
In order to make Cambodia independent from importing a product for the treatment and prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a collaboration for the development of a range of products for the treatment and prevention of malnutrition. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Malnutrition, Children, Treatment
- What is being tested?
- 2 months of treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCambodia
- Study dates
- 1 Apr 2016to May 2019
- Phase
- Interventional
- 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
- discharged from hospital after admission for SAM
- WHZ <2.8 Z-score or MUAC<11.5 cm
- no complications
- passing the appetite test
Who cannot join
- <6 mo of age
- complications related to SAM
Trial locations and contacts
1 site in 1 country.
Cambodia1 site
Department of Fisheries Post-harvest Technologies and Quality Control, Fisheries Administration
Phnom Penh
About this study
Official title: Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM in Cambodia
In order to make Cambodia independent from importing a product for the treatment and prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a collaboration for the development of a range of products for the treatment and prevention of malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances, the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The main objective of this sub-study is to test the efficacy of the newly developed RUTF on the recovery of children suffering from severe acute malnutrition. As comparison, the current treatment of SAM with BP-100 will be used.
- Conditions
- Malnutrition, Children, Treatment
- Being tested
- 2 months of treatment
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 months of treatmentDietary supplement
standard 2 months of treatment
| Study group | Role | What they receive |
|---|---|---|
| BP-100 | Active comparator | standard treatment Receives: Dietary Supplement: 2 months of treatment |
| Num Trey | Experimental | locally produced RUTF Receives: Dietary Supplement: 2 months of treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
weight gain in g/kg/day
Measured: 2 months
Secondary outcomes (2)
body composition
changes in body composition obtained from skinfold thickness measurements over the treatment period
Measured: 2 months
Fatty Acid composition
changes in serum concentrations of fatty acids over the intervention period
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Apr 2016
- Primary completion15 Jan 2017
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Ministry of Agriculture, Forestry and Fisheries Cambodia, UNICEF
- Responsible party
- Principal investigator, Frank Wieringa, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907424
- Sponsor's protocol ID
- IRD_UNICEF_DFPTQ_SAM
- Acronym
- FLNS_SAM
- Status last verified
- May 2018
- First submitted
- 12 Sep 2016
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Sigh S, Lauritzen L, Wieringa FT, Laillou A, Chamnan C, Stark KD, Roos N. Changes in polyunsaturated fatty acids during treatment of malnourished children may be insufficient to reach required essential fatty acid levels - A randomised controlled trial. Clin Nutr. 2023 Sep;42(9):1778-1787. doi: 10.1016/j.clnu.2023.08.003. Epub 2023 Aug 6.
PubMed 37572581Sigh S, Lauritzen L, Wieringa FT, Laillou A, Chamnan C, Angkeabos N, Moniboth D, Berger J, Stark KD, Roos N. Whole-blood PUFA and associations with markers of nutritional and health status in acutely malnourished children in Cambodia. Public Health Nutr. 2020 Apr;23(6):974-986. doi: 10.1017/S1368980019003744. Epub 2020 Jan 24.
PubMed 31973779
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Locally Produced RUTF With a Commercial RUTF in the Treatment of SAM in Cambodia
- ClinicalTrials.gov ID
- NCT02907424
- Acronym / sponsor ID
- FLNS_SAM / IRD_UNICEF_DFPTQ_SAM
- Conditions
- Malnutrition, Children, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Ministry of Agriculture, Forestry and Fisheries Cambodia, UNICEF
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 15 Jan 2017 (actual)
- Study completion
- May 2019 (estimated)
- First posted
- 20 Sep 2016 (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.
In order to make Cambodia independent from importing a product for the treatment and prevention of malnutrition, UNICEF, DFPTQ Fisheries Administration and IRD have started a collaboration for the development of a range of products for the treatment and prevention of malnutrition. To reduce costs of the product, and to adapt the taste to local circumstances, the protein source of the usual RUTF (milk powder) has been changed to fish (Trey Riel). The main objective of this sub-study is to test the efficacy of the newly developed RUTF on the recovery of children suffering from severe acute malnutrition. As comparison, the current treatment of SAM with BP-100 will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP-100 | Active comparator | Dietary Supplement: 2 months of treatmentstandard treatment |
| Num Trey | Experimental | Dietary Supplement: 2 months of treatmentlocally produced RUTF |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- discharged from hospital after admission for SAM
- WHZ <2.8 Z-score or MUAC<11.5 cm
- no complications
- passing the appetite test
Key exclusion criteria (2 listed)
- <6 mo of age
- complications related to SAM
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 |
|---|---|---|
| 2 months of treatmentstandard 2 months of treatment | Dietary supplement | BP-100, Num Trey |
Primary outcome
weight gain
Time frame: 2 months
weight gain in g/kg/day
2 secondary outcomes
body composition
Time frame: 2 months
Fatty Acid composition
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 37572581Sigh S, Lauritzen L, Wieringa FT, Laillou A, Chamnan C, Stark KD, Roos N. Changes in polyunsaturated fatty acids during treatment of malnourished children may be insufficient to reach required essential fatty acid levels - A randomised controlled trial. Clin Nutr. 2023 Sep;42(9):1778-1787. doi: 10.1016/j.clnu.2023.08.003. Epub 2023 Aug 6.
- Derived from this study: PubMed 31973779Sigh S, Lauritzen L, Wieringa FT, Laillou A, Chamnan C, Angkeabos N, Moniboth D, Berger J, Stark KD, Roos N. Whole-blood PUFA and associations with markers of nutritional and health status in acutely malnourished children in Cambodia. Public Health Nutr. 2020 Apr;23(6):974-986. doi: 10.1017/S1368980019003744. Epub 2020 Jan 24.
- Individual participant dataSharing planned: Yes
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 months of treatment in people with Malnutrition and Children, run by Institut de Recherche pour le Developpement at 1 site in Cambodia.
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 2 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: status not confirmed, as of the sponsor's last update on 16 May 2018. 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 Cambodia. 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.
Are results available for this study?
Results are not available in the source record.
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?
weight gain (time frame: 2 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 NCT02907424, which also lists 2 linked publications.
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 16 May 2018.