Acute Malnutrition in Infancy (Disorder)NCT04698070
Optimizing Acute Malnutrition Management in Children Aged 6 to 59 Months in Niger (OptIMA Niger)
A study testing Nutritional Strategy - OptiMA, Nutritional Strategy - ComPAS and National nutritional Strategy (Niger) in people with Acute Malnutrition in Infancy (Disorder), run by Alliance for International Medical Action at 4 sites in Niger.
Trial summary
Acute malnutrition (AM) is a continuum condition, arbitrarily divided into severe and moderate categories (SAM, MAM) which are managed separately, with programs overseen by different agencies with different products and supply chains. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Malnutrition in Infancy (Disorder)
- What is being tested?
- Nutritional Strategy - OptiMA, Nutritional Strategy - ComPAS and National nutritional Strategy (Niger)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,304 participants
- Where
- 4 sitesNiger
- Study dates
- 22 Mar 2021to 24 Jun 2022
- 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
- Age 6 to 59 months old upon study inclusion
- Meet one of the acute malnutrition criteria defined as follows:
- MUAC < 125mm or
- Weight for Length Z-score <-3 (WHO standard) or
- Oedema grade + or ++;
- Resident in health area where the study is conducted ;
- Child's mother or guardian provides informed consent.
Who cannot join
- Children with medical condition requiring hospitalization or negative appetite test or oedema grade +++;
- Children allergic to milk, peanuts and/or RUTFs ;
- Children diagnosed with a chronic pathology such as sickle cell anemia, trisomy 21, congenital heart disease, neurological condition;
- Children currently enrolled in another malnutrition programme.
Trial locations and contacts
4 sites in 1 country.
Niger4 sites
Diney
Mirriah, Zinder Region
Droum
Mirriah, Zinder Region
Gada
Mirriah, Zinder Region
Gaffati
Mirriah, Zinder Region
About this study
Official title: Evaluation of Two Optimizing and Simplifying Strategies on Acute Malnutrition Treatment in Children Aged 6 to 59 Months in Mirriah District, Zinder, Niger
Acute malnutrition (AM) is a continuum condition, arbitrarily divided into severe and moderate categories (SAM, MAM) which are managed separately, with programs overseen by different agencies with different products and supply chains. Such separation complicates delivery of care, contributes to poor program performance, and creates confusion among caregivers. Reduction in the mortality burden from AM will stem from improved simplicity, efficiency and cost-effectiveness of current protocols.
Eligibility for SAM treatment in the current Niger protocol is complex. It is determined by 3 independent criteria: nutritional oedema, Mid-Upper Arm Circumference (MUAC) < 115 mm or weight-height Z score (WHZ) <-3. Also, the Ready to Use Therapeutic Food (RUTF) ration in Niger protocol (130-200 kcal/kg/d) is paradoxical. The amount of RUTF prescribed in the first weeks of treatment is often less than what given to child reaching recovery (MUAC > 125 and WHZ >-2), because weekly ration is determined by the child's weight. Rate of weight gain is highest in the first two weeks of treatment, then plateaus - suggesting no benefit of increased RUTF ration at the end of treatment. Progressive reduction is a more rational use of RUTF and this supplement is equally effective for SAM and MAM.
Read more
This community-based non-inferiority trial will compare two strategies for the treatment of AM to the Niger protocol for SAM and MAM. The Optimizing treatment for acute MAlnutrition (OptiMA) strategy uses MUAC < 125 mm or nutritional oedema as admission criteria and optimizes RUTF by adapting doses to the degree of malnutrition. RUTF dose for MUAC < 115 mm or oedema is 170 kcal/kg/d and progressively reduces to 75 kcal/kg/d as MUAC increases. The Combined Protocol for Acute Malnutrition Study (ComPAS) uses the same eligibility criteria like OptiMA, but simplifies more the RUTF ration by providing 1000 kcal/d for children with oedema or MUAC < 115 mm and 500 kg/d for children with MUAC 115-124 mm. Children are considered recovered if they have 2 consecutive weekly MUAC measures ≥ 125 mm.
Children will be individually randomized to treatment in one of the 3 study arms and will attend clinic visits weekly until nutritional recovery. After discharged, they will be monitored monthly via a nurse-conducted home visits until 6 months post-inclusion. The trial arms will be compared using a composite outcome indicator that includes vital status, anthropometric measures and relapse following the index AM episode.
The hypothesis is that simplified strategies could substantially increase the number of children in care compared to current SAM programs without requiring additional RUTF or staffing while maintaining recovery rates in line with current programs.
Read the detailed description
The main outcome, the success rate, is defined by a composite of three endpoints : alive, not acutely malnourished per the definition applied at inclusion and not having an additional episode of AM throughout the 6- month observation period. All other children are classified as 'unsuccessful'.
The secondary major outcome, the recovery rate, is defined by reaching during the 6 month follow-up a MUAC>=125 and no oedema during two consecutive weeks, a minimum RUTF treatment period of 4 weeks and good clinical condition.
Sample size:
For the main objective, the expected success rate is 68% with a statistical power of 90%. For the secondary priority objective n°1, the expected recovery rate is 82% and for the secondary priority objective n°2, the expected recovery rate is 74% with a statistical power of 80%. For all objectives, the margin of non-inferiority set is 10% with a level of significance set at 1.25% unilaterally. An inflation of 5% to account for unexploitable data was also added. The number of randomized subjects required is:
- 568 participants to meet the main objective;
- 295 participants with severe acute malnutrition to meet the secondary priority objective n°1.
- 384 participants with MUAC<115mm at admission to meet the secondary priority objective n°2.
Data collection and monitoring :
A paper form will be completed by the trial nurses during the outpatient follow-up or at home visits. Data will be recorded by data entry agents supervised by a data manager using RedCAP software.
Data monitoring will be performed every week at each site by clinical trial monitors under the responsibility of the research activities manager, according to the recommendations of Good Clinical Practices. All data entered in the database will be checked for completeness and consistency. The methods of data entry, coding, control, validation and database freezing will be described in a "data management" guide. Before the implementation of the trial, a monitoring plan will be established.
Analysis :
Before the end of the inclusion period, a statistical analysis plan will be established.
The occurrence of the primary endpoint (success rate) will be compared between the OptiMA and ComPAS strategies to the standard protocol.
The occurrence of the primary secondary endpoint (recovery rate) will be compared between the OptiMA and ComPAS strategies to the standard protocol, for children randomized in the severe acute malnourished stratum and for children admitted with a MUAC<115mm.
These comparisons will be made by Intention To Treat (ITT) (including all randomized participants), and Per-Protocol (PP) (including only those participants who received the full randomized treatment strategy).
The primary analysis (success in the overall population regardless of the level of malnutrition) and the main secondary analysis (recovery rate in the "severely malnourished" stratum) in ITT and PP are non-inferiority analyses.
The OptiMA and ComPAS strategies will be deemed non-inferior to the standard strategy if the primary and main secondary analysis statistically demonstrate non-inferiority in both ITT and PP.
The primary analyses in terms of success and recovery will be performed on available data. In case of missing data, a sensitivity analysis will be performed using the maximum bias method. Missing data can be vital status if the child is absent at the last visit, and anthropometric data (weight, MUAC, height). In the case of missing height data, the last available height can be taken into consideration given the low variability of this value from one month to the next.
The probabilities of success, recovery and relapse in each of the strategies and the quantities of RUTF consumed per child to achieve recovery will serve to construct a cost-effectiveness model.
- Conditions
- Acute Malnutrition in Infancy (Disorder)
- Being tested
- Nutritional Strategy - OptiMA, Nutritional Strategy - ComPAS, National nutritional Strategy (Niger)
- Keywords
- Acute malnutrition, Randomized Clinical Trial, Child Malnutrition, Severe acute malnutrition, Moderate acute malnutrition, Niger, Sub-Saharan Africa, MUAC
- Medical subject headings
- Child Nutrition Disorders, Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional Strategy - OptiMADietary supplement
All children randomized to this arm will be treated with a RUTF, with weekly ration determined according to MUAC, weight and presence of nutritional edema. Ration will be adjusted weekly according to the change in MUAC and weight throughout the outpatient follow-up until the child achieves nutritional recovery.
RUTF dosage will 170 kcal/kg/d for the most severely wasted (MUAC < 115 mm or edema) and reduced to 125 kcal/kg/d for children with MUAC 115-119mm and 75 kcal/kg/d for children with MUAC 120-124 mm.
All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet nutritional recovery criteria, and then a monthly community-based follow-up in their villages (vital status, anthropometric measures and clinical condition). Referral to the health facility for appropriate nutritional/medical care if illness or acute malnutrition relapse detected).
Nutritional Strategy - ComPASDietary supplement
All children randomized to this arm will be treated with RUTF, with weekly ration determined according to MUAC and presence of nutritional edema. Children enrolled with MUAC < 115 mm or edema will receive 1000 kcal/d (2 sachets/day) RUTF until MUAC has surpassed 115 mm and/or edema is resolved for 2 weeks at which time ration will be reduced to 500 kcal/d (1 sachet/day) until MUAC > or = to 125 mm is achieved for 2 consecutive weeks. Children enrolled with MUAC 115-124 mm will receive 1 sachet/day until MUAC > or = 125 mm is achieved for 2 consecutive weeks and clinically well. Following nutritional recovery, a study nurse will conduct monthly community-based follow-up in their villages (vital status, anthropometric measures and clinical condition) with referral to the health facility for appropriate nutritional/medical care if illness or acute malnutrition relapse detected) for the remainder of the 6 month period following inclusion.
National nutritional Strategy (Niger)Other
Different protocols for SAM and MAM comprise the Niger National Nutrition Protocol:
- SAM: Children with MUAC<115 or WHZ<-3 or nutritional edema, will be treated with RUTF, according to a dosage table based on weight at each visit.
- MAM: Children aged between 6-24 months with MUAC between 115 -124 mm and WHZ>-3 will be treated with RUSF. Children with the same anthropometry but age 24-59 m will only receive supplementation if they develop criteria for SAM during the 6 month study period. They will be monitored via monthly home visits by a study nurse.
All children 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).
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | RUTF 130-200 kcal/kg/day for children with nutritional edema or MUAC < 115 mm or WHZ <-3 and RUSF 500 kcal/d for children 6-23 months with WHZ between -2 and -3 Z and MUAC 115-124 mm. Receives: Other: National nutritional Strategy (Niger) |
| OptiMA | Experimental | RUTF 170 kcal/kg/d for children with nutritional edema or MUAC < 115 mm; 125 kcal/kg/d for MUAC 115-119 mm and 75 kcal/kg/d for MUAC 120-124 mm. Receives: Dietary Supplement: Nutritional Strategy - OptiMA |
| ComPAS | Experimental | RUTF 1000 kcal/d for children with nutritional edema or MUAC < 115 mm and 500 kcal/day for MUAC 115-124 mm. Receives: Dietary Supplement: Nutritional Strategy - ComPAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
The primary outcome is a binary composite indicator. Children classified as 'success' fulfil all of the following criteria: alive, not acutely malnourished per the definition applied at inclusion and no additional episode of acute malnutrition (inclusion criteria) throughout the 6-month observation period. All other children are classified unsuccessful.
Measured: 6-month after randomisation
Secondary outcomes (2)
Recovery rate in children with SAM WHO definition
The secondary priority outcome n°1 is the recovery rate in participants with severe acute malnutrition (WHO definition)defined as follows: absence of bipedal oedema and MUAC > 125 mm during two consecutive weeks, a 4-week minimum duration of treatment as clinically well, i.e. axillary temperature <37.5°C. This outcome will be measured throughout the 6-month observation period. All children reaching these criteria during outpatient treatment our during the home visit will be defined recovered.
Measured: Throughout the 6-month observation period
Recovery rate in children with MUAC<115mm
The secondary priority outcome n°2 is the recovery rate in participants with MUAC<115mm defined as follows: absence of bipedal oedema and MUAC > 125 mm during two consecutive weeks, a 4-week minimum duration of treatment as clinically well, i.e. axillary temperature <37.5°C. This outcome will be measured throughout the 6-month observation period. All children reaching these criteria during outpatient treatment our during the home visit will be defined recovered.
Measured: Throughout the 6-month observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start22 Mar 2021
- Primary completion22 Mar 2022
- Study completion24 Jun 2022
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 Acute Malnutrition in Infancy (Disorder)Studies 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
- Masking
- None (open label)
- Enrolment
- 2,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for International Medical Action
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Susan Shepherd, MD, Principal investigator, Alliance for International Medical ActionRenaud Becquet, MPH,PhD,HDR, Principal investigator, Inserm U1219 Bordeaux Population Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698070
- Sponsor's protocol ID
- 35237
- Status last verified
- Sep 2022
- First submitted
- 19 Dec 2020
- Last updated
- 23 Sep 2022
- 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
Daures M, Hien J, Phelan K, Boubacar H, Atte S, Aboubacar M, Aly AAGM, Mayoum B, Azani JC, Koffi JJ, Seri B, Beuscart A, Gabillard D, Hubert V, Cazes C, Kinda M, Anglaret X, Kangas S, Shepherd S, Becquet R. Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a 3 arms community-based individually randomised controlled trial in decentralised Niger. Trials. 2022 Jan 28;23(1):89. doi: 10.1186/s13063-021-05955-6.
PubMed 35090531
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Optimizing and Simplifying Strategies on Acute Malnutrition Treatment in Children Aged 6 to 59 Months in Mirriah District, Zinder, Niger
- ClinicalTrials.gov ID
- NCT04698070
- Acronym / sponsor ID
- 35237
- Conditions
- Acute Malnutrition in Infancy (Disorder)
- Keywords
- Acute malnutrition, Randomized Clinical Trial, Child Malnutrition, Severe acute malnutrition, Moderate acute malnutrition, Niger, Sub-Saharan Africa, MUAC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,304 participants (actual)
- Lead sponsor
- Alliance for International Medical ActionUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), University of Bordeaux
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 22 Mar 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 6 Jan 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.
Acute malnutrition (AM) is a continuum condition, arbitrarily divided into severe and moderate categories (SAM, MAM) which are managed separately, with programs overseen by different agencies with different products and supply chains. Such separation complicates delivery of care, contributes to poor program performance, and creates confusion among caregivers. Reduction in the mortality burden from AM will stem from improved simplicity, efficiency and cost-effectiveness of current protocols.
Eligibility for SAM treatment in the current Niger protocol is complex. It is determined by 3 independent criteria: nutritional oedema, Mid-Upper Arm Circumference (MUAC) < 115 mm or weight-height Z score (WHZ) <-3. Also, the Ready to Use Therapeutic Food (RUTF) ration in Niger protocol (130-200 kcal/kg/d) is paradoxical. The amount of RUTF prescribed in the first weeks of treatment is often less than what given to child reaching recovery (MUAC > 125 and WHZ >-2), because weekly ration is determined by the child's weight. Rate of weight gain is highest in the first two weeks of treatment, then plateaus - suggesting no benefit of increased RUTF ration at the end of treatment. Progressive reduction is a more rational use of RUTF and this supplement is equally effective for SAM and MAM.
This community-based non-inferiority trial will compare two strategies for the treatment of AM to the Niger protocol for SAM and MAM. The Optimizing treatment for acute MAlnutrition (OptiMA) strategy uses MUAC < 125 mm or nutritional oedema as admission criteria and optimizes RUTF by adapting doses to the degree of malnutrition. RUTF dose for MUAC < 115 mm or oedema is 170 kcal/kg/d and progressively reduces to 75 kcal/kg/d as MUAC increases. The Combined Protocol for Acute Malnutrition Study (ComPAS) uses the same eligibility criteria like OptiMA, but simplifies more the RUTF ration by providing 1000 kcal/d for children with oedema or MUAC < 115 mm and 500 kg/d for children with MUAC 115-124 mm. Children are considered recovered if they have 2 consecutive weekly MUAC measures ≥ 125 mm.
Children will be individually randomized to treatment in one of the 3 study arms and will attend clinic visits weekly until nutritional recovery. After discharged, they will be monitored monthly via a nurse-conducted home visits until 6 months post-inclusion. The trial arms will be compared using a composite outcome indicator that includes vital status, anthropometric measures and relapse following the index AM episode.
The hypothesis is that simplified strategies could substantially increase the number of children in care compared to current SAM programs without requiring additional RUTF or staffing while maintaining recovery rates in line with current programs.
Detailed description
The main outcome, the success rate, is defined by a composite of three endpoints : alive, not acutely malnourished per the definition applied at inclusion and not having an additional episode of AM throughout the 6- month observation period. All other children are classified as 'unsuccessful'.
The secondary major outcome, the recovery rate, is defined by reaching during the 6 month follow-up a MUAC>=125 and no oedema during two consecutive weeks, a minimum RUTF treatment period of 4 weeks and good clinical condition.
Sample size:
For the main objective, the expected success rate is 68% with a statistical power of 90%. For the secondary priority objective n°1, the expected recovery rate is 82% and for the secondary priority objective n°2, the expected recovery rate is 74% with a statistical power of 80%. For all objectives, the margin of non-inferiority set is 10% with a level of significance set at 1.25% unilaterally. An inflation of 5% to account for unexploitable data was also added. The number of randomized subjects required is:
- 568 participants to meet the main objective;
- 295 participants with severe acute malnutrition to meet the secondary priority objective n°1.
- 384 participants with MUAC<115mm at admission to meet the secondary priority objective n°2.
Data collection and monitoring :
A paper form will be completed by the trial nurses during the outpatient follow-up or at home visits. Data will be recorded by data entry agents supervised by a data manager using RedCAP software.
Data monitoring will be performed every week at each site by clinical trial monitors under the responsibility of the research activities manager, according to the recommendations of Good Clinical Practices. All data entered in the database will be checked for completeness and consistency. The methods of data entry, coding, control, validation and database freezing will be described in a "data management" guide. Before the implementation of the trial, a monitoring plan will be established.
Analysis :
Before the end of the inclusion period, a statistical analysis plan will be established.
The occurrence of the primary endpoint (success rate) will be compared between the OptiMA and ComPAS strategies to the standard protocol.
The occurrence of the primary secondary endpoint (recovery rate) will be compared between the OptiMA and ComPAS strategies to the standard protocol, for children randomized in the severe acute malnourished stratum and for children admitted with a MUAC<115mm.
These comparisons will be made by Intention To Treat (ITT) (including all randomized participants), and Per-Protocol (PP) (including only those participants who received the full randomized treatment strategy).
The primary analysis (success in the overall population regardless of the level of malnutrition) and the main secondary analysis (recovery rate in the "severely malnourished" stratum) in ITT and PP are non-inferiority analyses.
The OptiMA and ComPAS strategies will be deemed non-inferior to the standard strategy if the primary and main secondary analysis statistically demonstrate non-inferiority in both ITT and PP.
The primary analyses in terms of success and recovery will be performed on available data. In case of missing data, a sensitivity analysis will be performed using the maximum bias method. Missing data can be vital status if the child is absent at the last visit, and anthropometric data (weight, MUAC, height). In the case of missing height data, the last available height can be taken into consideration given the low variability of this value from one month to the next.
The probabilities of success, recovery and relapse in each of the strategies and the quantities of RUTF consumed per child to achieve recovery will serve to construct a cost-effectiveness model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Other: National nutritional Strategy (Niger)RUTF 130-200 kcal/kg/day for children with nutritional edema or MUAC < 115 mm or WHZ <-3 and RUSF 500 kcal/d for children 6-23 months with WHZ between -2 and -3 Z and MUAC 115-124 mm. |
| OptiMA | Experimental | Dietary Supplement: Nutritional Strategy - OptiMARUTF 170 kcal/kg/d for children with nutritional edema or MUAC < 115 mm; 125 kcal/kg/d for MUAC 115-119 mm and 75 kcal/kg/d for MUAC 120-124 mm. |
| ComPAS | Experimental | Dietary Supplement: Nutritional Strategy - ComPASRUTF 1000 kcal/d for children with nutritional edema or MUAC < 115 mm and 500 kcal/day for MUAC 115-124 mm. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age 6 to 59 months old upon study inclusion
- Meet one of the acute malnutrition criteria defined as follows:
- Resident in health area where the study is conducted ;
- Child's mother or guardian provides informed consent.
Key exclusion criteria (4 listed)
- Children with medical condition requiring hospitalization or negative appetite test or oedema grade +++;
- Children allergic to milk, peanuts and/or RUTFs ;
- Children diagnosed with a chronic pathology such as sickle cell anemia, trisomy 21, congenital heart disease, neurological condition;
- Children currently enrolled in another 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 randomized to this arm will be treated with a RUTF, with weekly ration determined according to MUAC, weight and presence of nutritional edema. Ration will be adjusted weekly according to the change in MUAC and weight throughout the outpatient follow-up until the child achieves nutritional recovery. RUTF dosage will 170 kcal/kg/d for the most severely wasted (MUAC < 115 mm or edema) and reduced to 125 kcal/kg/d for children with MUAC 115-119mm and 75 kcal/kg/d for children with MUAC 120-124 mm. All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet nutritional recovery criteria, and then a monthly community-based follow-up in their villages (vital status, anthropometric measures and clinical condition). Referral to the health facility for appropriate nutritional/medical care if illness or acute malnutrition relapse detected). | Dietary supplement | OptiMA |
| Nutritional Strategy - ComPASAll children randomized to this arm will be treated with RUTF, with weekly ration determined according to MUAC and presence of nutritional edema. Children enrolled with MUAC < 115 mm or edema will receive 1000 kcal/d (2 sachets/day) RUTF until MUAC has surpassed 115 mm and/or edema is resolved for 2 weeks at which time ration will be reduced to 500 kcal/d (1 sachet/day) until MUAC > or = to 125 mm is achieved for 2 consecutive weeks. Children enrolled with MUAC 115-124 mm will receive 1 sachet/day until MUAC > or = 125 mm is achieved for 2 consecutive weeks and clinically well. Following nutritional recovery, a study nurse will conduct monthly community-based follow-up in their villages (vital status, anthropometric measures and clinical condition) with referral to the health facility for appropriate nutritional/medical care if illness or acute malnutrition relapse detected) for the remainder of the 6 month period following inclusion. | Dietary supplement | ComPAS |
| National nutritional Strategy (Niger)Different protocols for SAM and MAM comprise the Niger National Nutrition Protocol: 1. SAM: Children with MUAC<115 or WHZ<-3 or nutritional edema, will be treated with RUTF, according to a dosage table based on weight at each visit. 2. MAM: Children aged between 6-24 months with MUAC between 115 -124 mm and WHZ>-3 will be treated with RUSF. Children with the same anthropometry but age 24-59 m will only receive supplementation if they develop criteria for SAM during the 6 month study period. They will be monitored via monthly home visits by a study nurse. All children 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). | Other | Standard |
Primary outcome
Success rate
Time frame: 6-month after randomisation
The primary outcome is a binary composite indicator. Children classified as 'success' fulfil all of the following criteria: alive, not acutely malnourished per the definition applied at inclusion and no additional episode of acute malnutrition (inclusion criteria) throughout the 6-month observation period. All other children are classified unsuccessful.
2 secondary outcomes
Recovery rate in children with SAM WHO definition
Time frame: Throughout the 6-month observation period
Recovery rate in children with MUAC<115mm
Time frame: Throughout the 6-month observation period
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 23 Sep 2022.
- Derived from this study: PubMed 35090531Daures M, Hien J, Phelan K, Boubacar H, Atte S, Aboubacar M, Aly AAGM, Mayoum B, Azani JC, Koffi JJ, Seri B, Beuscart A, Gabillard D, Hubert V, Cazes C, Kinda M, Anglaret X, Kangas S, Shepherd S, Becquet R. Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a 3 arms community-based individually randomised controlled trial in decentralised Niger. Trials. 2022 Jan 28;23(1):89. doi: 10.1186/s13063-021-05955-6.
- Description ALIMA websiteLink provided by the sponsor.
- 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).
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.
Susan Shepherd, MD principal investigator
Alliance for International Medical Action
Renaud Becquet, MPH,PhD,HDR principal investigator
Inserm U1219 Bordeaux Population Health Center
4 sites 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, Nutritional Strategy - ComPAS and National nutritional Strategy (Niger) in people with Acute Malnutrition in Infancy (Disorder), run by Alliance for International Medical Action at 4 sites in Niger.
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 7 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 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Niger. 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 (time frame: 6-month after randomisation). 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 NCT04698070, 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 23 Sep 2022.