Severe Acute MalnutritionNCT05015257
Effectiveness of Four Transition Dietary Regimens in the Hospital Management of Children With Kwashiorkor.
A study testing Standard F100, Standard F75 + Plumpynut and Alternative F75 with CMV + Plumpynut in people with Severe Acute Malnutrition and Kwashiorkor, run by University Ghent at 1 site in Burkina Faso.
Trial summary
In Burkina Faso the number of severely acute malnourished (SAM) children successfully treated has increased since the implementation of community-based management of acute malnutrition. SAM children with oedema have a higher risk of dying than SAM without oedema; they require inpatient care. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition, Kwashiorkor, Nutritional Edema
- What is being tested?
- Standard F100, Standard F75 + Plumpynut and Alternative F75 with CMV + Plumpynut
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 15 Sep 2021to 31 Aug 2023
- 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 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Severe acute malnutrition defined as the presence of edema
- Who are admitted and treated in the refeeding center (CREN) of the CHUSS
- Aged between 6 and 59 Months
- Parental Signed informed consent form
- Recruited in the first phase of the treatment and successfully admitted to the transition phase
Who cannot join
- SAM without edema
- Moderate acute malnutrition (MAM)
- Did not improve during the stabilization phase
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Centre Hospitalier Universitaire Souro
Bobo-Dioulasso, Bobo Dioulasso
About this study
Official title: The Underlying Causes Affecting the Response to Dietary Rehabilitation in Severely Acutely Malnourished Children at the Center Hôspitalier Universitaire Sourô Sanou, Bobo Dioulasso, Burkina Faso
In Burkina Faso the number of severely acute malnourished (SAM) children successfully treated has increased since the implementation of community-based management of acute malnutrition. SAM children with oedema have a higher risk of dying than SAM without oedema; they require inpatient care. Several theories have been proposed to explain the pathophysiology of oedema in SAM, but its etiology remains unclear. Knowledge on the nutritional adequacy of therapeutic regimens in kwashiorkor is limited. The World Health Organization (WHO) recommends to use in the treatment of complicated SAM a therapeutic milk 'F75' in the stabilization phase; F75+ready-to-use therapeutic foods (RUTF) or F100 at the transition phase. Alternatively the local formulas (maize flour, milk powder, oil, sugar, mineral-vitamin complex CMV) can be used in case of shortage or intolerance.
At the Nutritional Rehabilitation and Education Center of the University Hospital of Bobo Dioulasso it was found that some SAM children whose oedema resolved under F75 in the stabilization phase, re-developed oedema as they entered the transition phase with RUTF. RUTF has the same nutritional value as F100 but contains iron unlike F100 (<0.07 mg/100 mL). It was observed that RUTF in some cases may be associated with higher mortality, probably due to high iron content (10-14 mg/100 g), which may increase the risk of infections and the formation of free radicals, thereby increasing damage to the body's cells. Clinical trials evaluating the current guidelines for the treatment of SAM with oedema are scarce. A better understanding of the risk factors affecting the effectiveness of the nutritional therapeutic protocol for children with Kwashiorkor will be useful to improve their care.
The main objective of this study is to determine whether the use of transition phase diets (Plumpy-Nut®+F75 or F100 or alternative F75+/- CMV+ Plumpy-Nut®) affect oedema resolving in Kwashiorkor children and to investigate the underlying factors for the relapse or non-responsiveness to the therapeutic treatment.
Read the detailed description
Severe acute malnutrition (SAM) is a life threatening condition that requires urgent attention and appropriate management to reduce mortality and promote recovery among children. SAM is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 WHO growth standards, 2) a mid-upper arm circumference (MUAC) of less than 115 mm or 3) by the presence of nutritional edema. Signs such as edema, mucocutaneous changes, hepatomegaly, lethargy, anorexia, anemia, severe immune deficiency and rapid progression to mortality characterize a state commonly coined as "complicated SAM". Kwashiorkor (SAM with edema) is one of the forms of complicated SAM commonly distinguished by the unmistakable presence of bipedal edema. Kwashiorkor is characterized by the following clinical signs: 1) edemas symmetrical, painless, soft, bilateral, ascending, pitting; 2) lesions of the skin and integuments; 3) ulcerations and depigmentation; 4) alopecia; 5) constant weight loss marked by edema; 6) hepatomegaly; 7) clinical anemia; 8) intestinal transit disorders: persistent diarrhea, vomiting; 9) anorexia and behavioral disorders (apathy).
Severe acute malnutrition results in high mortality rates of up to half a million child deaths annually. Undernourished children are at higher risk of mortality ranging from three-times more risk among children with moderate malnutrition to 10-times in SAM children compared to well-nourished children.
The objective of this study is to determine whether the use of different transition phase diets affect oedema resolving in Kwashiorkor children and to investigate the underlying factors for the relapse or non-responsiveness to the therapeutic treatment.
Hypotheses to be tested
- The first hypothesis is that RUTF (Plumpy-Nut®) because of its content in iron may compromise the effectiveness of the transition phase in children with kwashiorkor
- The second hypothesis is that underlying factors including co-morbidities and epigenetics may explain a difference in response to therapeutic regimens
This is an open label randomized controlled trial to test the effectiveness of four used transition phase diets in Kwashiorkor children in their transition to the rehabilitation phase. The four dietary regimens that will be tested are:
- F100;
- RUTF+F75;
- RUTF+alternative F75 with complex mineral-vitamin (CMV); and
- RUTF+alternative F75 without CMV.
When it is decided to move to the transition phase, the child will be assigned to one of the treatments depending on the treatment received during the stabilization phase and the results of the appetite test. That is a child who accepts the Plumpy Nut will receive it in combination with their regimen they had during the stabilization phase. If a child does not accept Plumpy Nut, then they will received F100 regardless of their initial therapeutic food regimen.
- For those who received F75 in the stabilization phase, they will receive standard F75 + Plumpy Nut
- For those who received alternative F75 with CMV in the stabilization phase, they will receive alternative F75 with CMV + Plumpy Nut®
- For those who received alternative F75 without CMV in the stabilization phase, they will receive alternative F75 without CMV + Plumpy Nut®.
- Conditions
- Severe Acute Malnutrition, Kwashiorkor, Nutritional Edema
- Being tested
- Standard F100, Standard F75 + Plumpynut, Alternative F75 with CMV + Plumpynut, Alternative F75 without CMV + Plumpynut
- Keywords
- Severe acute malnutrition, Nutritional rehabilitation, F100, Transition phase, Therapeutic complex of vitamins and minerals (CMV), Kwashiorkor, Ready-to-use Therapeutic Food
- Medical subject headings
- Severe Acute Malnutrition, Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard F100Dietary supplement
100 kcal and 3 g protein per 100 ml
Standard F75 + PlumpynutDietary supplement
Standard F75 with ready to-use therapeutic food (Plumpynut)
Alternative F75 with CMV + PlumpynutDietary supplement
Alternative F75 containing CMV with ready to-use therapeutic food (Plumpynut)
Alternative F75 without CMV + PlumpynutDietary supplement
Alternative F75 with no CMV with ready to-use therapeutic food (Plumpynut)
| Study group | Role | What they receive |
|---|---|---|
| Standard F100 | Active comparator | If the test of appetite at the end of the stabilization phase is negative (the child does not accept the Plumpynut) Receives: Dietary Supplement: Standard F100 |
| Standard F75+Plumpynut | Experimental | If the test of appetite at the end of the stabilization phase is positive (the child accepts the Plumpynut) and the child received Standard F75 during the stabilization phase Receives: Dietary Supplement: Standard F75 + Plumpynut |
| Alternative F75 with CMV +Plumpynut | Experimental | If the test of appetite at the end of the stabilization phase is positive (the child accepts the Plumpynut) and the child received Alternative F75 with CMV during the stabilization phase Receives: Dietary Supplement: Alternative F75 with CMV + Plumpynut |
| Alternative F75 without CMV +Plumpynut | Experimental | If the test of appetite at the end of the stabilization phase is positive (the child accepts the Plumpynut) and the child received Alternative F75 without CMV during the stabilization phase Receives: Dietary Supplement: Alternative F75 without CMV + Plumpynut |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema redevelopment during the transition phase
Number of children whose edema redeveloped after it has been resolved during the stabilization phase
Measured: Three to Seven days
Severe adverse event
Any serious severe adverse event ranging from diarrhea, vomiting, anorexia to death
Measured: Three to Seven days
Secondary outcomes (5)
Mean number of days for a complete edema resolving
Number of days for a complete edema resolving among Kwashiorkor children, in Day
Measured: Three to Seven days
Intestinal microbiota
16S rRNA sequencing of DNA extracts of fecal samples
Measured: Three to Seven days
Presence of acidic stools
Measurement of stool potential Hydrogen (pH)
Measured: Three to Seven days
Soil Helminths
Determination of intestinal parasites using Quantitative Real-Time polymerase chain reaction (qPCR)
Measured: Three to Seven days
Epigenetics
In a subsample of children, DNA methylation is identified using Illumina Array Analysis Platform
Measured: Three to Seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start15 Sep 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 GhentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open label randomized controlled trial to test the effectiveness of four diets in Kwashiorkor children in their transition phase. When it is decided to move to the transition phase, the child will be assigned to one of the treatments depending on the treatment received during the stabilization phase and the results of the appetite test. That is a child who accepts the Plumpy Nut will receive it in combination with their regimen they had during the stabilization phase. If a child does not accept Plumpy Nut, then they will received F100 regardless of their initial therapeutic food regimen. * For those who received F75 in the stabilization phase, they will receive standard F75 + Plumpy Nut * For those who received alternative F75 with CMV in the stabilization phase, they will receive alternative F75 with CMV + Plumpy Nut® * For those who received alternative F75 without CMV in the stabilization phase, they will receive alternative F75 without CMV + Plumpy Nut®.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso), Centre Muraz
- Responsible party
- Sponsor
- Investigators
- Stefaan De Henauw, Md. PhD, Principal investigator, University GhentSouheila Abbeddou, MSc. PhD, Principal investigator, University GhentJerome Some, Md. PhD, Principal investigator, Institut de Recherche en Sciences de la Sante, Burkina FasoBintou Sanogo, MSc. Md., Principal investigator, Centre Hospitalier Universitaire Souro, Bobo Dioulasso, Burkina Faso.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015257
- Sponsor's protocol ID
- BC-09443-B
- Status last verified
- Oct 2023
- First submitted
- 2 Aug 2021
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary
Publications
Gopalan C. Kwashiorkor and marasmus: evolution and distinguishing features. 1968. Natl Med J India. 1992 May-Jun;5(3):145-51. No abstract available.
PubMed 1306670Nguefack F, Adjahoung CA, Keugoung B, Kamgaing N, Dongmo R. [Hospital management of severe acute malnutrition in children with F-75 and F-100 alternative local preparations: results and challenges]. Pan Afr Med J. 2015 Aug 31;21:329. doi: 10.11604/pamj.2015.21.329.6632. eCollection 2015. French.
PubMed 26587175Singh K, Badgaiyan N, Ranjan A, Dixit HO, Kaushik A, Kushwaha KP, Aguayo VM. Management of children with severe acute malnutrition: experience of Nutrition Rehabilitation Centers in Uttar Pradesh, India. Indian Pediatr. 2014 Jan;51(1):21-5. doi: 10.1007/s13312-014-0328-9. Epub 2013 Jul 5.
PubMed 24277964Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, Kau AL, Rich SS, Concannon P, Mychaleckyj JC, Liu J, Houpt E, Li JV, Holmes E, Nicholson J, Knights D, Ursell LK, Knight R, Gordon JI. Gut microbiomes of Malawian twin pairs discordant for kwashiorkor. Science. 2013 Feb 1;339(6119):548-54. doi: 10.1126/science.1229000. Epub 2013 Jan 30.
PubMed 23363771
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Underlying Causes Affecting the Response to Dietary Rehabilitation in Severely Acutely Malnourished Children at the Center Hôspitalier Universitaire Sourô Sanou, Bobo Dioulasso, Burkina Faso
- ClinicalTrials.gov ID
- NCT05015257
- Acronym / sponsor ID
- BC-09443-B
- Conditions
- Severe Acute Malnutrition, Kwashiorkor, Nutritional Edema
- Keywords
- Severe acute malnutrition, Nutritional rehabilitation, F100, Transition phase, Therapeutic complex of vitamins and minerals (CMV), Kwashiorkor, Ready-to-use Therapeutic Food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Institut de Recherche en Sciences de la Sante, Burkina Faso, University Hospital Sourô Sanou of Bobo Dioulasso (Burkina Faso), Centre Muraz
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 20 Aug 2021 (actual)
- 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 Burkina Faso the number of severely acute malnourished (SAM) children successfully treated has increased since the implementation of community-based management of acute malnutrition. SAM children with oedema have a higher risk of dying than SAM without oedema; they require inpatient care. Several theories have been proposed to explain the pathophysiology of oedema in SAM, but its etiology remains unclear. Knowledge on the nutritional adequacy of therapeutic regimens in kwashiorkor is limited. The World Health Organization (WHO) recommends to use in the treatment of complicated SAM a therapeutic milk 'F75' in the stabilization phase; F75+ready-to-use therapeutic foods (RUTF) or F100 at the transition phase. Alternatively the local formulas (maize flour, milk powder, oil, sugar, mineral-vitamin complex CMV) can be used in case of shortage or intolerance.
At the Nutritional Rehabilitation and Education Center of the University Hospital of Bobo Dioulasso it was found that some SAM children whose oedema resolved under F75 in the stabilization phase, re-developed oedema as they entered the transition phase with RUTF. RUTF has the same nutritional value as F100 but contains iron unlike F100 (<0.07 mg/100 mL). It was observed that RUTF in some cases may be associated with higher mortality, probably due to high iron content (10-14 mg/100 g), which may increase the risk of infections and the formation of free radicals, thereby increasing damage to the body's cells. Clinical trials evaluating the current guidelines for the treatment of SAM with oedema are scarce. A better understanding of the risk factors affecting the effectiveness of the nutritional therapeutic protocol for children with Kwashiorkor will be useful to improve their care.
The main objective of this study is to determine whether the use of transition phase diets (Plumpy-Nut®+F75 or F100 or alternative F75+/- CMV+ Plumpy-Nut®) affect oedema resolving in Kwashiorkor children and to investigate the underlying factors for the relapse or non-responsiveness to the therapeutic treatment.
Detailed description
Severe acute malnutrition (SAM) is a life threatening condition that requires urgent attention and appropriate management to reduce mortality and promote recovery among children. SAM is defined by 1) a weight-for-height Z-score more than three standard deviations (SD) below the median based on the 2006 WHO growth standards, 2) a mid-upper arm circumference (MUAC) of less than 115 mm or 3) by the presence of nutritional edema. Signs such as edema, mucocutaneous changes, hepatomegaly, lethargy, anorexia, anemia, severe immune deficiency and rapid progression to mortality characterize a state commonly coined as "complicated SAM". Kwashiorkor (SAM with edema) is one of the forms of complicated SAM commonly distinguished by the unmistakable presence of bipedal edema. Kwashiorkor is characterized by the following clinical signs: 1) edemas symmetrical, painless, soft, bilateral, ascending, pitting; 2) lesions of the skin and integuments; 3) ulcerations and depigmentation; 4) alopecia; 5) constant weight loss marked by edema; 6) hepatomegaly; 7) clinical anemia; 8) intestinal transit disorders: persistent diarrhea, vomiting; 9) anorexia and behavioral disorders (apathy).
Severe acute malnutrition results in high mortality rates of up to half a million child deaths annually. Undernourished children are at higher risk of mortality ranging from three-times more risk among children with moderate malnutrition to 10-times in SAM children compared to well-nourished children.
The objective of this study is to determine whether the use of different transition phase diets affect oedema resolving in Kwashiorkor children and to investigate the underlying factors for the relapse or non-responsiveness to the therapeutic treatment.
Hypotheses to be tested
- The first hypothesis is that RUTF (Plumpy-Nut®) because of its content in iron may compromise the effectiveness of the transition phase in children with kwashiorkor
- The second hypothesis is that underlying factors including co-morbidities and epigenetics may explain a difference in response to therapeutic regimens
This is an open label randomized controlled trial to test the effectiveness of four used transition phase diets in Kwashiorkor children in their transition to the rehabilitation phase. The four dietary regimens that will be tested are:
- F100;
- RUTF+F75;
- RUTF+alternative F75 with complex mineral-vitamin (CMV); and
- RUTF+alternative F75 without CMV.
When it is decided to move to the transition phase, the child will be assigned to one of the treatments depending on the treatment received during the stabilization phase and the results of the appetite test. That is a child who accepts the Plumpy Nut will receive it in combination with their regimen they had during the stabilization phase. If a child does not accept Plumpy Nut, then they will received F100 regardless of their initial therapeutic food regimen.
- For those who received F75 in the stabilization phase, they will receive standard F75 + Plumpy Nut
- For those who received alternative F75 with CMV in the stabilization phase, they will receive alternative F75 with CMV + Plumpy Nut®
- For those who received alternative F75 without CMV in the stabilization phase, they will receive alternative F75 without CMV + Plumpy Nut®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is an open label randomized controlled trial to test the effectiveness of four diets in Kwashiorkor children in their transition phase. When it is decided to move to the transition phase, the child will be assigned to one of the treatments depending on the treatment received during the stabilization phase and the results of the appetite test. That is a child who accepts the Plumpy Nut will receive it in combination with their regimen they had during the stabilization phase. If a child does not accept Plumpy Nut, then they will received F100 regardless of their initial therapeutic food regimen. * For those who received F75 in the stabilization phase, they will receive standard F75 + Plumpy Nut * For those who received alternative F75 with CMV in the stabilization phase, they will receive alternative F75 with CMV + Plumpy Nut® * For those who received alternative F75 without CMV in the stabilization phase, they will receive alternative F75 without CMV + Plumpy Nut®.
| Arm | Type | Receives |
|---|---|---|
| Standard F100 | Active comparator | Dietary Supplement: Standard F100If the test of appetite at the end of the stabilization phase is negative (the child does not accept the Plumpynut) |
| Standard F75+Plumpynut | Experimental | Dietary Supplement: Standard F75 + PlumpynutIf the test of appetite at the end of the stabilization phase is positive (the child accepts the Plumpynut) and the child received Standard F75 during the stabilization phase |
| Alternative F75 with CMV +Plumpynut | Experimental | Dietary Supplement: Alternative F75 with CMV + PlumpynutIf the test of appetite at the end of the stabilization phase is positive (the child accepts the Plumpynut) and the child received Alternative F75 with CMV during the stabilization phase |
| Alternative F75 without CMV +Plumpynut | Experimental | Dietary Supplement: Alternative F75 without CMV + PlumpynutIf the test of appetite at the end of the stabilization phase is positive (the child accepts the Plumpynut) and the child received Alternative F75 without CMV during the stabilization phase |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Severe acute malnutrition defined as the presence of edema
- Who are admitted and treated in the refeeding center (CREN) of the CHUSS
- Aged between 6 and 59 Months
- Parental Signed informed consent form
- Recruited in the first phase of the treatment and successfully admitted to the transition phase
Key exclusion criteria (3 listed)
- SAM without edema
- Moderate acute malnutrition (MAM)
- Did not improve during the stabilization phase
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 |
|---|---|---|
| Standard F100100 kcal and 3 g protein per 100 ml | Dietary supplement | Standard F100 |
| Standard F75 + PlumpynutStandard F75 with ready to-use therapeutic food (Plumpynut) | Dietary supplement | Standard F75+Plumpynut |
| Alternative F75 with CMV + PlumpynutAlternative F75 containing CMV with ready to-use therapeutic food (Plumpynut) | Dietary supplement | Alternative F75 with CMV +Plumpynut |
| Alternative F75 without CMV + PlumpynutAlternative F75 with no CMV with ready to-use therapeutic food (Plumpynut) | Dietary supplement | Alternative F75 without CMV +Plumpynut |
Primary outcome
Edema redevelopment during the transition phase
Time frame: Three to Seven days
Number of children whose edema redeveloped after it has been resolved during the stabilization phase
Severe adverse event
Time frame: Three to Seven days
Any serious severe adverse event ranging from diarrhea, vomiting, anorexia to death
5 secondary outcomes
Mean number of days for a complete edema resolving
Time frame: Three to Seven days
Intestinal microbiota
Time frame: Three to Seven days
Presence of acidic stools
Time frame: Three to Seven days
Soil Helminths
Time frame: Three to Seven days
Epigenetics
Time frame: Three to Seven days
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 3 Oct 2023.
- Background: PubMed 1306670Gopalan C. Kwashiorkor and marasmus: evolution and distinguishing features. 1968. Natl Med J India. 1992 May-Jun;5(3):145-51. No abstract available.
- Background: PubMed 26587175Nguefack F, Adjahoung CA, Keugoung B, Kamgaing N, Dongmo R. [Hospital management of severe acute malnutrition in children with F-75 and F-100 alternative local preparations: results and challenges]. Pan Afr Med J. 2015 Aug 31;21:329. doi: 10.11604/pamj.2015.21.329.6632. eCollection 2015. French.
- Background: PubMed 24277964Singh K, Badgaiyan N, Ranjan A, Dixit HO, Kaushik A, Kushwaha KP, Aguayo VM. Management of children with severe acute malnutrition: experience of Nutrition Rehabilitation Centers in Uttar Pradesh, India. Indian Pediatr. 2014 Jan;51(1):21-5. doi: 10.1007/s13312-014-0328-9. Epub 2013 Jul 5.
- Background: PubMed 23363771Smith MI, Yatsunenko T, Manary MJ, Trehan I, Mkakosya R, Cheng J, Kau AL, Rich SS, Concannon P, Mychaleckyj JC, Liu J, Houpt E, Li JV, Holmes E, Nicholson J, Knights D, Ursell LK, Knight R, Gordon JI. Gut microbiomes of Malawian twin pairs discordant for kwashiorkor. Science. 2013 Feb 1;339(6119):548-54. doi: 10.1126/science.1229000. Epub 2013 Jan 30.
- World Health Organization (2013) WHO guideline: updates on the management of severe acute malnutrition in infants and childrenLink provided by the sponsor.
- Ministère de la Sante au Burkina Faso. Protocol National : Prise en charge intégrée de la malnutrition aigüe (PCIMA). 2014Link provided by the sponsor.
- Individual participant dataSharing planned: No. All the data that can affect the main or the secondary outcomes will be used in the analyses and shared as necessary
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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.
Stefaan De Henauw, Md. PhD principal investigator
University Ghent
Souheila Abbeddou, MSc. PhD principal investigator
University Ghent
Jerome Some, Md. PhD principal investigator
Institut de Recherche en Sciences de la Sante, Burkina Faso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard F100, Standard F75 + Plumpynut and Alternative F75 with CMV + Plumpynut in people with Severe Acute Malnutrition and Kwashiorkor, run by University Ghent at 1 site in Burkina Faso.
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 5 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 3 Oct 2023. 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 Burkina Faso. 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?
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?
Edema redevelopment during the transition phase (time frame: Three to Seven days). The study lists 2 primary outcomes in all. 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 NCT05015257, which also lists 4 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 3 Oct 2023.