Severe Acute MalnutritionOptiMA-DRCNCT03751475
Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Democratic Republic of Congo
A study testing Nutritional Strategy - OptiMA and Effective nutritional standard strategy in people with Severe Acute Malnutrition and Moderate Acute Malnutrition, run by Alliance for International Medical Action at 1 site in Democratic Republic of the Congo.
Trial summary
Acute malnutrition affects 51 million children under the age of 5 worldwide. Malnutrition contributes to nearly half of all child deaths each year, with the forms characterized by wasting or oedema (acute malnutrition) associated with the highest risk of death. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition, Moderate Acute Malnutrition, Child Malnutrition
- What is being tested?
- Nutritional Strategy - OptiMA and Effective nutritional standard strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 896 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 22 Jul 2019to 20 Jul 2020
- 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
- Be between 6 and 59 months old;
- Meet one of the acute malnutrition criteria defined as follows: PB < 125mm or ratio Weight/Size (Z-score) <-3 (WHO standard) or Oedema of grade +, ++;
- Be resident in the health area where the active screening session takes place;
- Have the free, informed and signed consent of the child's mother or guardian.
Who cannot join
- Children with medical complication or negative appetite test or oedema (grade +++)
- Children allergic to milk or peanuts;
- Children suffering from a known chronic pathology such as sickle cell anemia, trisomy 21, congenital heart disease, or neurological condition;
- Children currently in a malnutrition programme.
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Health Zone
Kamuesha, Kasai Province
About this study
Official title: Optimized and Simplified Management of Acute Malnutrition in Children Aged 6 to 59 Months: a Community-based Clinical Randomized Controlled Trial in the Democratic Republic of Congo
Acute malnutrition affects 51 million children under the age of 5 worldwide. Malnutrition contributes to nearly half of all child deaths each year, with the forms characterized by wasting or oedema (acute malnutrition) associated with the highest risk of death.
Although acute malnutrition is a continuum condition, it is arbitrarily divided into severe and moderate acute malnutrition (SAM, MAM) which are managed separately, with programs overseen by different UN agencies, and using different protocols and products. Such separation complicates delivery of care, contributes to high default and low coverage, and creates confusion among caregivers. Often treatment is only available for SAM children resulting in lives lost and costly hospitalisation that could be averted if nutritional support were available earlier in the wasting process. If we are to reduce the health and mortality burden from malnutrition, the effectiveness and cost-effectiveness of current protocols need dramatic improvements.
Read more
The dosage of Ready to Use Therapeutic Food (RUTF) for SAM (130-200 kcal/kg/d) has not changed since introduction of out-patient protocols in the mid-2000s. Children classified as SAM in these protocols are determined by three independent criteria: the presence of nutritional oedema or MUAC < 115 mm or weight-height Z score <-3. The RUTF dosage in these protocols is paradoxical in that the absolute amount of RUTF prescribed in the initial phases of treatment is often less than that given as the child nears recovery, because the number of packets in the weekly ration is determined by weight. However, rate of weight gain (g/kg/day) is highest in the first two weeks of treatment, and then plateaus - suggesting no benefit of increased RUTF amounts in the later phases of treatment. Progressive reduction seems to be a more rational use of RUTF.
The Optimizing treatment for acute MAlnutrition (OptiMA) strategy consists in simplifying management of acute malnutrition through the use of a single anthropometric admission criterion (mid upper arm circumference [MUAC] < 125 mm or nutritional oedema) - one that best captures children's anthropometry related mortality risk- and by optimizing the use of RUTF by adapting doses to the nutritional recovery of the child. RUTF doses begin at 170 kcal/kg/d for the most severely wasted (MUAC < 115 mm or oedema) and reduce to 75 kcal/kg/d as oedema resolves and MUAC increases > 120 mm.
The investigators hypothesize that this strategy could double the number of children in care compared to current SAM programs without substantially increasing the amount of RUTF or staffing required while maintaining a recovery rate in line with current programs. OptiMA may also improve coverage and reduce the need for hospitalization through early identification of malnourished children.
The investigators propose to conduct a community-based non-inferiority clinical trial with individual randomization comparing the OptiMA strategy to the Democratic Republic of Congo standard nutritional protocol for SAM. Study children will be randomly assigned to the intervention arm or control arm - with children at MUAC < 125 mm or oedema eligible for RUTF in the intervention arm and those meeting current WHO SAM definition eligible in the control group. All participants will be followed for 9 months post-randomization to assess non-inferiority as defined by a composite of three endpoints : alive, acceptable nutritional status (MUAC ≥ 125 mm and WHZ >-3, no oedema) and no relapse to acute malnutrition for those who were treated with RUTF. The main secondary outcome will assess the non-inferiority of OptiMA RUTF dosing (170 kcal/kg/d) in children meeting current WHO SAM criteria compared to children with the same criteria in the control arm who will receive 130-200 kcal/kg/d.
Read the detailed description
The OptiMA strategy proposes a new malnutrition management approach, grounded in 3 main principles.
Firstly, the diagnosis of acute malnutrition is refined to target those at highest mortality risk within the CMAM definition of acute malnutrition (WHZ < -2 or MUAC < 125 mm or oedema), by targeting treatment to children with a MUAC < 125 mm or oedema. The simplicity of MUAC measure allows families to screen children and check for oedema at home and identify malnourished children at an earlier stage. The diagnosis is quickly confirmed by clinicians at the health center. MUAC progression is also used to monitor recovery and determine discharge thus eliminating the discrepancies that occur when both MUAC and WHZ are used to diagnose acute malnutrition.
Secondly, RUTF dosage is rationalized, and calibrated to the child's degree of wasting. The WHZ tables and dosing tables are replaced by a single table that determines the child's RUTF ration based on MUAC category and weight. Larger rations, on a per kilo basis, are given to the most severely malnourished and the ration is reduced as the child progresses to recovery.
Thirdly, supply chain is simplified to a single RUTF and data management from 2 programs are merged into one. This streamlined programme should result in better coverage, a high proportion of children detected before MUAC<115 mm, lower RUTF consumption per child and fewer acute malnutrition related hospitalisations.
- Conditions
- Severe Acute Malnutrition, Moderate Acute Malnutrition, Child Malnutrition, Acute Malnutrition, Congo, The Democratic Republic of the, Africa
- Being tested
- Nutritional Strategy - OptiMA, Effective nutritional standard strategy
- Keywords
- Acute Malnutrition, Severe Acute Malnutrition, Moderate Acute Malnutrition, Child Malnutrition, Congo, The Democratic Republic of the, Randomized Clinical Trial, Africa
- Medical subject headings
- Severe Acute Malnutrition, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Strategy - OptiMAOther
All children with a MUAC<125mm or oedema will be treated with the same RUTF, according to a new dosage table based on the evolution of MUAC and weight during recovery (RUTF dosage prescribed is gradually reduced as weight and MUAC increase).
All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet discharge criteria, and then a bimonthly community-based follow-up in their villages (vital \& anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated).
Effective nutritional standard strategyOther
Children presenting with MUAC<115 or WHZ<-3 or nutritional oedema, will be treated with RUTF, according to the usual dosage table based on weight at each visit.
All children (whether eligible for RUTF or not) will be followed-up for 6 months following randomization. Children eligible for RUTF at randomization will have a weekly outpatient visit in the health facility until they meet discharge criteria, and then a bi-monthly community-based follow-up in their villages (vital \& anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated). Children not eligible for RUTF at randomization will benefit from this same monthly community-based follow-up.
| Study group | Role | What they receive |
|---|---|---|
| OptiMA | Experimental | The enrolled subjects will follow the nutritional Optima strategy. Receives: Other: Nutritional Strategy - OptiMA |
| Control | Active comparator | The enrolled subjects will follow the standard nutritional protocol currently in use in the Democratic Republic of Congo Receives: Other: Effective nutritional standard strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate in each arm
Success is defined by a composite indicator evaluated 6 months post-randomization:
- child alive and not acutely malnourished, per the same definition at inclusion : absence of oedema and MUAC ≥125mm and WHZ ≥-3 and
- for the duration of the 6-month observation period following randomization, the child does not develop another episode of acute malnutrition applying the same definition at study inclusion.
Measured: 6 months after randomization
Secondary outcomes (1)
Recovery rate in participants with severe acute malnutrition (WHO definition)
The recovery rate is defined by a MUAC≥125 (OptiMA arm) and a MUAC≥125 or a WHZ>-1.5 (Standard Protocol arm) during two consecutive visits, absence of oedema, minimum treatment period of 4 weeks and good clinical condition
Measured: After RUTF treatment, through the 6 month study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start22 Jul 2019
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
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.
- 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
- 2 parallel arms stratified on site and degree of acute malnutrition. 890 participants for the principal objective 480 participants with severe acute malnutrition for the secondary main objective
- Masking
- None (open label)
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, The Innocent Foundation, University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- SHEPHERD SUSAN, MD, Principal investigator, Alliance for International Medical ActionBECQUET RENAUD, MPH, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751475
- Sponsor's protocol ID
- OptiMA-DRC
- Acronym
- OptiMA-DRC
- Status last verified
- Sep 2024
- First submitted
- 19 Nov 2018
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research findings will be disseminated in peer-reviewed journals, meetings and international conferences. Individual participant data will be accessible through controlled access repositories, after deidentification (text, tables, figures, and appendices).
Publications
Cazes C, Phelan K, Hubert V, Alitanou R, Boubacar H, Izie Bozama L, Tshibangu Sakubu G, Beuscart A, Yao C, Gabillard D, Kinda M, Augier A, Anglaret X, Shepherd S, Becquet R. Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasai, Democratic Republic of Congo. BMJ Open. 2020 Dec 2;10(12):e041213. doi: 10.1136/bmjopen-2020-041213.
PubMed 33268424Cazes C, Phelan K, Hubert V, Boubacar H, Bozama LI, Sakubu GT, Tshiala BK, Tusuku T, Alitanou R, Kouame A, Yao C, Gabillard D, Kinda M, Daures M, Augier A, Anglaret X, Shepherd S, Becquet R. Simplifying and optimising the management of uncomplicated acute malnutrition in children aged 6-59 months in the Democratic Republic of the Congo (OptiMA-DRC): a non-inferiority, randomised controlled trial. Lancet Glob Health. 2022 Apr;10(4):e510-e520. doi: 10.1016/S2214-109X(22)00041-9.
PubMed 35303461Cazes C, Phelan K, Hubert V, Boubacar H, Bozama LI, Sakubu GT, Senge BB, Baya N, Alitanou R, Kouame A, Yao C, Gabillard D, Daures M, Augier A, Anglaret X, Kinda M, Shepherd S, Becquet R. Optimising the dosage of ready-to-use therapeutic food in children with uncomplicated severe acute malnutrition in the Democratic Republic of the Congo: a non-inferiority, randomised controlled trial. EClinicalMedicine. 2023 Feb 28;58:101878. doi: 10.1016/j.eclinm.2023.101878. eCollection 2023 Apr.
PubMed 36915287Hubert V, Phelan K, Bozama LI, Boubacar H, Sakubu GT, Tshiala B, Savy M, Becquet R, Cazes C. Food insecurity, feeding practices and associated factors of acute malnutrition among children under 5 years of age in a post-conflict context in the Kasai region, Democratic Republic of Congo: a community-based case-control study. BMC Nutr. 2025 May 30;11(1):106. doi: 10.1186/s40795-025-01096-0.
PubMed 40448235
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized and Simplified Management of Acute Malnutrition in Children Aged 6 to 59 Months: a Community-based Clinical Randomized Controlled Trial in the Democratic Republic of Congo
- ClinicalTrials.gov ID
- NCT03751475
- Acronym / sponsor ID
- OptiMA-DRC / OptiMA-DRC
- Conditions
- Severe Acute Malnutrition, Moderate Acute Malnutrition, Child Malnutrition, Acute Malnutrition, Congo, The Democratic Republic of the, Africa
- Keywords
- Acute Malnutrition, Severe Acute Malnutrition, Moderate Acute Malnutrition, Child Malnutrition, Congo, The Democratic Republic of the, Randomized Clinical Trial, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, The Innocent Foundation, University of Bordeaux
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 23 Nov 2018 (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.
Acute malnutrition affects 51 million children under the age of 5 worldwide. Malnutrition contributes to nearly half of all child deaths each year, with the forms characterized by wasting or oedema (acute malnutrition) associated with the highest risk of death.
Although acute malnutrition is a continuum condition, it is arbitrarily divided into severe and moderate acute malnutrition (SAM, MAM) which are managed separately, with programs overseen by different UN agencies, and using different protocols and products. Such separation complicates delivery of care, contributes to high default and low coverage, and creates confusion among caregivers. Often treatment is only available for SAM children resulting in lives lost and costly hospitalisation that could be averted if nutritional support were available earlier in the wasting process. If we are to reduce the health and mortality burden from malnutrition, the effectiveness and cost-effectiveness of current protocols need dramatic improvements.
The dosage of Ready to Use Therapeutic Food (RUTF) for SAM (130-200 kcal/kg/d) has not changed since introduction of out-patient protocols in the mid-2000s. Children classified as SAM in these protocols are determined by three independent criteria: the presence of nutritional oedema or MUAC < 115 mm or weight-height Z score <-3. The RUTF dosage in these protocols is paradoxical in that the absolute amount of RUTF prescribed in the initial phases of treatment is often less than that given as the child nears recovery, because the number of packets in the weekly ration is determined by weight. However, rate of weight gain (g/kg/day) is highest in the first two weeks of treatment, and then plateaus - suggesting no benefit of increased RUTF amounts in the later phases of treatment. Progressive reduction seems to be a more rational use of RUTF.
The Optimizing treatment for acute MAlnutrition (OptiMA) strategy consists in simplifying management of acute malnutrition through the use of a single anthropometric admission criterion (mid upper arm circumference [MUAC] < 125 mm or nutritional oedema) - one that best captures children's anthropometry related mortality risk- and by optimizing the use of RUTF by adapting doses to the nutritional recovery of the child. RUTF doses begin at 170 kcal/kg/d for the most severely wasted (MUAC < 115 mm or oedema) and reduce to 75 kcal/kg/d as oedema resolves and MUAC increases > 120 mm.
The investigators hypothesize that this strategy could double the number of children in care compared to current SAM programs without substantially increasing the amount of RUTF or staffing required while maintaining a recovery rate in line with current programs. OptiMA may also improve coverage and reduce the need for hospitalization through early identification of malnourished children.
The investigators propose to conduct a community-based non-inferiority clinical trial with individual randomization comparing the OptiMA strategy to the Democratic Republic of Congo standard nutritional protocol for SAM. Study children will be randomly assigned to the intervention arm or control arm - with children at MUAC < 125 mm or oedema eligible for RUTF in the intervention arm and those meeting current WHO SAM definition eligible in the control group. All participants will be followed for 9 months post-randomization to assess non-inferiority as defined by a composite of three endpoints : alive, acceptable nutritional status (MUAC ≥ 125 mm and WHZ >-3, no oedema) and no relapse to acute malnutrition for those who were treated with RUTF. The main secondary outcome will assess the non-inferiority of OptiMA RUTF dosing (170 kcal/kg/d) in children meeting current WHO SAM criteria compared to children with the same criteria in the control arm who will receive 130-200 kcal/kg/d.
Detailed description
The OptiMA strategy proposes a new malnutrition management approach, grounded in 3 main principles.
Firstly, the diagnosis of acute malnutrition is refined to target those at highest mortality risk within the CMAM definition of acute malnutrition (WHZ < -2 or MUAC < 125 mm or oedema), by targeting treatment to children with a MUAC < 125 mm or oedema. The simplicity of MUAC measure allows families to screen children and check for oedema at home and identify malnourished children at an earlier stage. The diagnosis is quickly confirmed by clinicians at the health center. MUAC progression is also used to monitor recovery and determine discharge thus eliminating the discrepancies that occur when both MUAC and WHZ are used to diagnose acute malnutrition.
Secondly, RUTF dosage is rationalized, and calibrated to the child's degree of wasting. The WHZ tables and dosing tables are replaced by a single table that determines the child's RUTF ration based on MUAC category and weight. Larger rations, on a per kilo basis, are given to the most severely malnourished and the ration is reduced as the child progresses to recovery.
Thirdly, supply chain is simplified to a single RUTF and data management from 2 programs are merged into one. This streamlined programme should result in better coverage, a high proportion of children detected before MUAC<115 mm, lower RUTF consumption per child and fewer acute malnutrition related hospitalisations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 parallel arms stratified on site and degree of acute malnutrition. 890 participants for the principal objective 480 participants with severe acute malnutrition for the secondary main objective
| Arm | Type | Receives |
|---|---|---|
| OptiMA | Experimental | Other: Nutritional Strategy - OptiMAThe enrolled subjects will follow the nutritional Optima strategy. |
| Control | Active comparator | Other: Effective nutritional standard strategyThe enrolled subjects will follow the standard nutritional protocol currently in use in the Democratic Republic of Congo |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Be between 6 and 59 months old;
- Meet one of the acute malnutrition criteria defined as follows: PB < 125mm or ratio Weight/Size (Z-score) <-3 (WHO standard) or Oedema of grade +, ++;
- Be resident in the health area where the active screening session takes place;
- Have the free, informed and signed consent of the child's mother or guardian.
Key exclusion criteria (4 listed)
- Children with medical complication or negative appetite test or oedema (grade +++)
- Children allergic to milk or peanuts;
- Children suffering from a known chronic pathology such as sickle cell anemia, trisomy 21, congenital heart disease, or neurological condition;
- Children currently in a malnutrition programme.
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 |
|---|---|---|
| Nutritional Strategy - OptiMAAll children with a MUAC<125mm or oedema will be treated with the same RUTF, according to a new dosage table based on the evolution of MUAC and weight during recovery (RUTF dosage prescribed is gradually reduced as weight and MUAC increase). All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet discharge criteria, and then a bimonthly community-based follow-up in their villages (vital \& anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated). | Other | OptiMA |
| Effective nutritional standard strategyChildren presenting with MUAC<115 or WHZ<-3 or nutritional oedema, will be treated with RUTF, according to the usual dosage table based on weight at each visit. All children (whether eligible for RUTF or not) will be followed-up for 6 months following randomization. Children eligible for RUTF at randomization will have a weekly outpatient visit in the health facility until they meet discharge criteria, and then a bi-monthly community-based follow-up in their villages (vital \& anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated). Children not eligible for RUTF at randomization will benefit from this same monthly community-based follow-up. | Other | Control |
Primary outcome
Success rate in each arm
Time frame: 6 months after randomization
Success is defined by a composite indicator evaluated 6 months post-randomization: * child alive and not acutely malnourished, per the same definition at inclusion : absence of oedema and MUAC ≥125mm and WHZ ≥-3 and * for the duration of the 6-month observation period following randomization, the child does not develop another episode of acute malnutrition applying the same definition at study inclusion.
1 secondary outcome
Recovery rate in participants with severe acute malnutrition (WHO definition)
Time frame: After RUTF treatment, through the 6 month study completion
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 25 Sep 2024.
- Background: PubMed 33268424Cazes C, Phelan K, Hubert V, Alitanou R, Boubacar H, Izie Bozama L, Tshibangu Sakubu G, Beuscart A, Yao C, Gabillard D, Kinda M, Augier A, Anglaret X, Shepherd S, Becquet R. Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasai, Democratic Republic of Congo. BMJ Open. 2020 Dec 2;10(12):e041213. doi: 10.1136/bmjopen-2020-041213.
- Results publication: PubMed 35303461Cazes C, Phelan K, Hubert V, Boubacar H, Bozama LI, Sakubu GT, Tshiala BK, Tusuku T, Alitanou R, Kouame A, Yao C, Gabillard D, Kinda M, Daures M, Augier A, Anglaret X, Shepherd S, Becquet R. Simplifying and optimising the management of uncomplicated acute malnutrition in children aged 6-59 months in the Democratic Republic of the Congo (OptiMA-DRC): a non-inferiority, randomised controlled trial. Lancet Glob Health. 2022 Apr;10(4):e510-e520. doi: 10.1016/S2214-109X(22)00041-9.
- Results publication: PubMed 36915287Cazes C, Phelan K, Hubert V, Boubacar H, Bozama LI, Sakubu GT, Senge BB, Baya N, Alitanou R, Kouame A, Yao C, Gabillard D, Daures M, Augier A, Anglaret X, Kinda M, Shepherd S, Becquet R. Optimising the dosage of ready-to-use therapeutic food in children with uncomplicated severe acute malnutrition in the Democratic Republic of the Congo: a non-inferiority, randomised controlled trial. EClinicalMedicine. 2023 Feb 28;58:101878. doi: 10.1016/j.eclinm.2023.101878. eCollection 2023 Apr.
- Derived from this study: PubMed 40448235Hubert V, Phelan K, Bozama LI, Boubacar H, Sakubu GT, Tshiala B, Savy M, Becquet R, Cazes C. Food insecurity, feeding practices and associated factors of acute malnutrition among children under 5 years of age in a post-conflict context in the Kasai region, Democratic Republic of Congo: a community-based case-control study. BMC Nutr. 2025 May 30;11(1):106. doi: 10.1186/s40795-025-01096-0.
- Individual participant dataSharing planned: Yes. The research findings will be disseminated in peer-reviewed journals, meetings and international conferences. Individual participant data will be accessible through controlled access repositories, after deidentification (text, tables, figures, and appendices).
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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.
SHEPHERD SUSAN, MD principal investigator
Alliance for International Medical Action
BECQUET RENAUD, MPH, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Strategy - OptiMA and Effective nutritional standard strategy in people with Severe Acute Malnutrition and Moderate Acute Malnutrition, run by Alliance for International Medical Action at 1 site in Democratic Republic of the Congo.
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 4 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 25 Sep 2024. 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 Democratic Republic of the Congo. 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?
Success rate in each arm (time frame: 6 months after randomization). 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 NCT03751475, 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 25 Sep 2024.