Modelling an alternative nutrition protocol generalizable for outpatient (MANGO)
| ISRCTN | ISRCTN50039021 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50039021 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/04/2016
- Registration date
- 13/05/2016
- Last edited
- 09/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Severe acute malnutrition in children under 5 is defined by being too thin for a given height and/or having the left arm circumference less than a given threshold (i.e. measuring how fat or thin the arm is), and/or having swollen feet (malnutrition oedema). It affects 19 million children under five at any point in time, and is likely to result in death if left untreated. Children can be treated in the hospital as in inpatient (hospitalized, for example, due to medical complications) or as outpatients, coming once a week to the closest health centre for monitoring and to receive treatment that they take at home. A very effective ambulatory (outpatient) treatment has been in place for several years and involves giving each patient an antibiotic and a therapeutic food made of peanut paste, vegetable oil, powdered milk, sugar, vitamins and minerals. The amount given to each child is matched to their individual nutritional needs. The treatment does work, however the children do gain less weight than expected. There have been reports that this may be partly due to the therapeutic food being shared with the family and it being sold on the market. It is also possible that malnourished children in the process of recovery may need less therapeutic food than currently provided. This study will test out this theory by giving children treated as outpatients a lesser amount of the therapeutic food to see whether they still gain the weight. Other effects of the treatment from admission to discharge will also be measured, including duration of the treatment, the recovery, how many stick with the treatment, how many are admitted to hospital, death and relapse rates from the nutritional programme, the changes in anthropometry (weight, height, arm circumference, leg length), average energy intake after 4 weeks of treatment, micronutrient blood status changes (that is, levels of nutrients in the blood), hair changes, body fat and lean masses changes. The cost of treatment will also be calculated and compared with costs for children given the more standard amount of therapeutic food.
Who can participate?
Children aged 6 to 59 months, diagnosed with severe acute malnutrition, without malnutrition oedema, without medical complications and having passed successfully an appetite test.
What does the study involve?
The children are randomly allocated to one of two groups. Those in group 1 are given the standard amount of therapeutic food. Those in group 2 are given the reduced amount of therapeutic food. For the first two weeks of treatment, all children are given the same amount. From week three, however, children in group 2 are given a reduced amount until their discharge from care. All children are also given the same basic medical treatment for the management of severe acute malnutrition.
What are the possible benefits and risks of participating?
All children will benefit of getting treatment for malnutrition. However, children in both groups may not gain a lot of weight, if any at all. They may also suffer from fever, diarrhea, cough, etc. which are all danger signs that means they have to be referred to hospital for treatment under 24-hour care, as per standard protocol. For the reduced dosage group, referral will be considered towards returning to a standard dosage, or to hospital, depending of the clinical assessment.
Where is the study run from?
The study will be run in 10 health centres of Fada N’Gourma district, located in the Eastern Region of Burkina Faso.
When is the study starting and how long is it expected to run for?
September 2015 to December 2017
Who is funding the study?
1. Children's Investment Fund Foundation (CIFF)
2. European Commission's Humanitarian aid and Civil Protection Department (ECHO)
3. Humanitarian Innovation Fund (HIF)
Who is the main contact?
Mrs Cécile Salpéteur (public)
csalpeteur@actioncontrelafaim.org
Contact information
Public
Action contre la Faim France
14/16 Boulevard de Douaumont
CS 80060
Paris
75854
France
| Phone | +33 1 70 84 73 49 |
|---|---|
| csalpeteur@actioncontrelafaim.org |
Study information
| Study design | Randomized controlled non-inferiority trial using individual randomization to allocate patients to either the intervention arm or control arm. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Modelling an Alternative Nutrition Protocol Generalizable for Outpatient (MANGO) - effectiveness of an optimized dosage of RUTF for the treatment of severe acute malnutrition: a randomized controlled, non-inferiority trial in Burkina Faso |
| Study acronym | MANGO Project |
| Study objectives | The proposed study hypothesizes that a reduced dose of RUTF starting at the third week of treatment among severely acutely malnourished children would result in equal weight gain and recovery from malnutrition as when children are receiving a full dose of RUTF throughout the treatment period. This hypothesis is based on the assumption that the full dose of RUTF is not consumed entirely by the malnourished child but shared with other family members or even sold. This assumption is based on various field observations and backed up by program data indicating a slower recovery than expected when considering the energy provided by the RUTF. |
| Ethics approval(s) | Ethical Committee on Health research of the Ministry of Health of Burkina Faso, 02/12/2015, ref: 2015-12-01 |
| Health condition(s) or problem(s) studied | Non-complicated severe acute malnutrition among children 6-59 months. |
| Intervention | The intervention tested is restricted to the nutritional treatment of malnourished children involving ready-to use therapeutic foods (RUTFs). The nutritional treatment protocol will be different between the 2 study groups. For the first 2 weeks of treatment, both the intervention and the control arm receive a standard dose of RUTF as per national protocol. However, from the third week onwards the intervention arm will receive a reduced dose while the control arm will continue on the full dose of RUTF. This will continue until discharge. The basic medical treatment of the children will be the same between the 2 groups and will follow the recommendations for the management of severe acute malnutrition as per the national protocol. The nutritional treatment scheme for the 2 groups is described below. Ration scheme Normal dose RUTF: Week 1 to discharge Weight (kg) Sachets/wk Kcal/kg/d 3.0-3.4 8 168-190 3.5-4.9 10 183-204 5.0-6.9 15 155-214 7.0-9.9 20 144-204 10.0-14.9 30 144-214 Optimised dose RUTF: Week 1-2 Week 3 to discharge Weight (kg) Sachets/wk Kcal/kg/d Sachets/wk Kcal/kg/d 3.0-3.4 8 168-190 7 147-167 3.5-4.9 10 183-204 7 102-143 5.0-6.9 15 155-214 7 72-100 7.0-9.9 20 144-204 14 101-143 10.0-14.9 30 144-214 14 67-100 |
| Intervention type | Other |
| Primary outcome measure | Childrens rate of weight gain (g/kg/d) during treatment, measured at admission, upon weekly visits, and at discharge. |
| Secondary outcome measures | 1. Duration of treatment (days) until recovery 2. Recovery rate, defaulter rate, mortality rate and transfer to hospital rate, measured monthly 3. Growth velocity and change in anthropometry (weight for height, height for age, weight for age, Mid Upper Arm Circumference), measured on a weekly basis from admission to discharge, and with monthly follow-up measurements during 4 months 4. Relapse rate 4 months after discharge 5. Cost-effectiveness ratio of the intervention to rehabilitate one child 6. Average energy intake (kcal/d) of the child during treatment week number 4 7. Level of vitamin A, iron and inflammation markers in the blood, measured at admission and discharge dates 8. Body composition status at admission and discharge, measuring bio-impedancemetry 9. Level of leptin in the blood, measured at admission, and discharge 10. Catabolism markers in hair, measured at admission, and last follow-up 4 months after discharge |
| Overall study start date | 01/01/2015 |
| Completion date | 01/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 750 severely acute malnourished children, with 375 in each arm |
| Total final enrolment | 801 |
| Key inclusion criteria | 1. Children aged 6 to 59 months 2. Diagnosed with uncomplicated SAM and eligible for CMAM treatment, defined as WHZ <-3 and/or MUAC <115mm 3. No pitting bilateral oedema 4. No medical complications 5. Passed a standardized appetite test |
| Key exclusion criteria | 1. Severe anaemia defined as haemoglobin concentration < 4g/dl 2. Plans to leave the catchment area within the next 6 months 3. Known peanut and/or milk allergy 4. Treatment for SAM already received within the last 6 months, including re-admissions after defaulting, relapses, and medical transfers 5. Malformations or handicap which may affect food intake such as cleft palate, cerebral palsy or Down’s syndrome |
| Date of first enrolment | 17/10/2016 |
| Date of final enrolment | 20/07/2018 |
Locations
Countries of recruitment
- Burkina Faso
Study participating centre
Burkina Faso
Sponsor information
Other
c/o Mrs Myriam Aït Aïssa, Research Senior Advisor
14/16 Boulevard Douaumont
CS 80060
Paris
75854
France
| Phone | +33 1 70 84 70 70 |
|---|---|
| maitaissa@actioncontrelafaim.org | |
| Website | http://www.actioncontrelafaim.org/ |
"ROR" |
https://ror.org/035j0tq82 |
Funders
Funder type
Charity
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/06/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of this trial will be published in peer-reviewed scientific journals and presented at international conferences and at a national level from 2018 onwards. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Cécile Salpéteur (csalpeteur@actioncontrelafaim.org) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/08/2019 | 16/12/2019 | Yes | No |
| Results article | results | 01/11/2020 | 12/02/2021 | Yes | No |
| Results article | results | 01/11/2020 | 12/02/2021 | Yes | No |
| Results article | results | 11/02/2021 | 12/02/2021 | Yes | No |
| Results article | 23/02/2021 | 11/08/2021 | Yes | No | |
| Results article | 01/06/2021 | 11/08/2021 | Yes | No | |
| Protocol (other) | 02/09/2022 | No | No | ||
| Statistical Analysis Plan | 02/09/2022 | No | No | ||
| Other publications | predictors of time to recovery and non-response | 31/05/2022 | 09/07/2024 | Yes | No |
| Other publications | sub-study vitamin B12 status | 08/08/2023 | 09/07/2024 | Yes | No |
Editorial Notes
09/07/2024: Publication references added.
02/09/2022: Protocol and statistical analysis plan added.
11/08/2021: Publication references added, contact details updated.
12/02/2021: Publication references added.
16/12/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. The address of Suvi Kangas was updated.
4. The plain English summary was updated to reflect these changes.
10/09/2018: The following changes have been made:
1. The recruitment end date has been changed from 31/07/2018 to 20/07/2018.
2. The overall trial end date has been changed from 30/04/2018 to 01/02/2019.
3. The intention to publish date has been changed from 31/01/2019 to 01/06/2019.
20/03/2017: Overall trial dates changed from 01/09/2015 - 31/12/2017 to 01/01/2015 - 30/4/2018. Recruitment dates changed from 01/06/2016 - 31/05/2017 to 17/10/2016 - 31/01/2018. Updated contact email. Intention to publish date was changed from 30/06/2018 to 31/01/2019.
