Acute Malnutrition in ChildhoodNCT05543759
Simplified Treatment Protocol for Acute Malnutrition in Venezuela
An observational study of Acute Malnutrition in Childhood and Wasting, run by UNICEF - Venezuela at 1 site in Venezuela.
Trial summary
Global acute malnutrition (GAM) in children under five is defined by being too thin for a given height and/or having the Mid-upper arm circumference less than a given threshold. GAM includes moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Acute Malnutrition in Childhood, Wasting, Child Malnutrition
- What is being tested?
- Ready-To-Use Therapeutic Food (RUTF)
- How many people
- 307 participants
- Where
- 1 siteVenezuela
- Study dates
- 5 Sep 2022to 30 Nov 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Eligible children are children aged 6-59 months of both sexes from households established permanently in the catchment area of the selected health posts or health centers, meeting the SAM or MAM acute malnutrition case definitions described above with no medical complications and disability, and whose caregiver has granted consent to participate.
Who may be able to join
- The child is between 6 and 23 months of age at inclusion.
- The mother must live in the study area from the time of inclusion.
- Mid-upper arm circumference (MUAC) <12.5 cm or WHZ <-2 or bilateral pitting edema.
- No serious medical complications.
- Positive appetite test.
- The consent of the mother or caregiver.
Who cannot join
- Congenital malformations that make anthropometric measurements impossible.
- Mother intends to leave the study area before six months.
- Presence of medical condition requiring referral for hospitalization.
Trial locations and contacts
1 site in 1 country.
Venezuela1 site
Distrito Capital, La Guaira, Miranda
Caracas, Distrito Federal, 1060
About this study
Official title: Simplified Combined Protocol for the Identification and Treatment of Acute Malnutrition in Venezuela
Global acute malnutrition (GAM) in children under five is defined by being too thin for a given height and/or having the Mid-upper arm circumference less than a given threshold. GAM includes moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). This study has been designed to generate new evidence about the simplified combined protocol for the identification and treatment of GAM in Venezuela. The objective of the study is to document the safety and effectiveness of the Venezuelan simplified treatment protocol for GAM, which includes reduced frequency of follow-up visits, single product use and optimized daily RUTF dose. This prospective longitudinal study was conducted in 19 centers treating GAM in children aged 6-59 months diagnosed with uncomplicated GAM, defined as WHZ <-2 or MUAC <125mm or ++ bilateral edema. Children will be prospectively followed for a total of 6 months, including the treatment phase and the immediate post-discharge weeks until 6 months. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment and changes in anthropometry (weight, height and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.
Read the detailed description
The general objective of the study is to document the safety and effectiveness of Venezuelan simplified treatment protocol for Acute malnutrition of reduced frequency of follow-up visits, single product use and optimized daily RUTF dose.
This will be a prospective longitudinal study assessing the Venezuelan Simplified Combined Protocol among children with uncomplicated acute malnutrition according to the definition case study recently adopted by the Implementation Guidance: Prevention, Early Detection and Treatment of Wasting in Children 0-59 Months through National Health Systems in the Context of Coronavirus Disease, United Nations Children's Fund and World/Health Organization, for a single arm cohort included in treatment.
Children will be prospectively followed for a total of 6 months including the treatment phase and the immediate post-discharge weeks until 6 months.
An economic evaluation component will be incorporated. The economic valuation will be carried out based on quantitative data. Cost data will be collected from accounting records where available and through a series of interviews with key informants including health workers, civil society organizations, relevant staff from non-governmental organizations and United Nations agencies. Total costs will be aggregated and presented as cost per child treated and cost per child per child recovered.
The study will be implemented in 19 Community Health Centers purposively chosen based on their acute malnutrition prevalence and operational constraints. All of them will be proportionally distributed in three central states of Venezuela (Distrito Capital, Miranda, and La Guaira).
The protocol will be implemented by health professionals from each institution, duly previously trained in applying the study protocol.
- Conditions
- Acute Malnutrition in Childhood, Wasting, Child Malnutrition
- Being tested
- Ready-To-Use Therapeutic Food (RUTF)
- Keywords
- Severe acute malnutrition, Moderate acute malnutrition, Ready-to-use therapeutic food, Malnutrition treatment, Venezuela, Mid-upper arm circumference, Wasting
- Medical subject headings
- Cachexia, 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.
Ready-To-Use Therapeutic Food (RUTF)Dietary supplement
- SAM [MUAC <115mm or WHZ <-3 or oedema (+/++)] = Two 92g sachets RUTF/day (Approx. 1000 kcal/day).
- MAM [MUAC 115mm<125mm or WHZ <-2] = One 92g sachet RUTF/day (Approx. 500 kcal/day).
| Study group | Role | What they receive |
|---|---|---|
| Cases | Children aged 6-59 months of both sexes from households established permanently in the catchment area of the selected health posts or health centers, meeting the SAM or MAM acute malnutrition case definitions described below with no medical complications and disability, and whose caregiver has granted consent to participate. Receives: Dietary Supplement: Ready-To-Use Therapeutic Food (RUTF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate
This indicator is defined as the number children who recovered from wasting, MAM and SAM according to national program criteria (WHZ>-2 and MUAC>=125mm and absence of bilateral edema for two consecutive visits, within 16 weeks of enrollment in the program) divided by the total number of treatment results recorded.
Measured: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Weight gain
Average weight change per month
Measured: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
MUAC gain
Average change in MUAC per month
Measured: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Duration of the treatment
Defined as the average number of weeks spent on treatment (enrollment and discharge) in children 6-59 months of age at enrollment, according to health registers
Measured: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Prevalence of relapse after discharge from the treatment
This indicator is defined as the proportion of children with WHZ-score <-2 or MUAC <125 mm or bilateral edema six months after the admission
Measured: at six months after the admission
Number of RUTF delivered per child
Average number of RUTF delivered per child (SAM/MAM)
Measured: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Cost per child
Average number of dollars that cost to recovery a child
Measured: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Secondary outcomes (4)
Longitudinal prevalence of wasting
This indicator is defined for each child as the number of visits during which nutritional wasting is observed divided by the total number of monthly visits made.
Measured: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
Prevalence of child stunting
Proportion of children with Height-for-age Z-score (LAZ)<-2 (according to the 2006 World Health Organization reference) at the end of the study
Measured: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
Prevalence of child morbidity
Defined by the number of days with symptoms of acute respiratory infections, fever, diarrhea (three or more loose or liquid stools per day) and malaria divided by the total number of days observed/reported in the recall period
Measured: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
Prevalence of readmission
Prevalence of children readmitted to the treatment within six months after after the admission
Measured: Up to 6 months, at 24 weeks after the admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start5 Sep 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Why it stopped: The sponsoring organization UNICEF-Venezuela with administrative control over the study decided to terminate it.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Malnutrition in ChildhoodStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 307 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- UNICEF - Venezuela
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zulay Gonzalez, MSc, Principal investigator, UNICEF - Venezuela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543759
- Sponsor's protocol ID
- 291021
- Status last verified
- May 2023
- First submitted
- 13 Sep 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simplified Combined Protocol for the Identification and Treatment of Acute Malnutrition in Venezuela
- ClinicalTrials.gov ID
- NCT05543759
- Acronym / sponsor ID
- 291021
- Conditions
- Acute Malnutrition in Childhood, Wasting, Child Malnutrition
- Keywords
- Severe acute malnutrition, Moderate acute malnutrition, Ready-to-use therapeutic food, Malnutrition treatment, Venezuela, Mid-upper arm circumference, Wasting
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The sponsoring organization UNICEF-Venezuela with administrative control over the study decided to terminate it.
- Enrolment
- 307 participants (actual)
- Lead sponsor
- UNICEF - VenezuelaUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 16 Sep 2022 (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.
Global acute malnutrition (GAM) in children under five is defined by being too thin for a given height and/or having the Mid-upper arm circumference less than a given threshold. GAM includes moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). This study has been designed to generate new evidence about the simplified combined protocol for the identification and treatment of GAM in Venezuela. The objective of the study is to document the safety and effectiveness of the Venezuelan simplified treatment protocol for GAM, which includes reduced frequency of follow-up visits, single product use and optimized daily RUTF dose. This prospective longitudinal study was conducted in 19 centers treating GAM in children aged 6-59 months diagnosed with uncomplicated GAM, defined as WHZ <-2 or MUAC <125mm or ++ bilateral edema. Children will be prospectively followed for a total of 6 months, including the treatment phase and the immediate post-discharge weeks until 6 months. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment and changes in anthropometry (weight, height and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.
Detailed description
The general objective of the study is to document the safety and effectiveness of Venezuelan simplified treatment protocol for Acute malnutrition of reduced frequency of follow-up visits, single product use and optimized daily RUTF dose.
This will be a prospective longitudinal study assessing the Venezuelan Simplified Combined Protocol among children with uncomplicated acute malnutrition according to the definition case study recently adopted by the Implementation Guidance: Prevention, Early Detection and Treatment of Wasting in Children 0-59 Months through National Health Systems in the Context of Coronavirus Disease, United Nations Children's Fund and World/Health Organization, for a single arm cohort included in treatment.
Children will be prospectively followed for a total of 6 months including the treatment phase and the immediate post-discharge weeks until 6 months.
An economic evaluation component will be incorporated. The economic valuation will be carried out based on quantitative data. Cost data will be collected from accounting records where available and through a series of interviews with key informants including health workers, civil society organizations, relevant staff from non-governmental organizations and United Nations agencies. Total costs will be aggregated and presented as cost per child treated and cost per child per child recovered.
The study will be implemented in 19 Community Health Centers purposively chosen based on their acute malnutrition prevalence and operational constraints. All of them will be proportionally distributed in three central states of Venezuela (Distrito Capital, Miranda, and La Guaira).
The protocol will be implemented by health professionals from each institution, duly previously trained in applying the study protocol.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Dietary Supplement: Ready-To-Use Therapeutic Food (RUTF)Children aged 6-59 months of both sexes from households established permanently in the catchment area of the selected health posts or health centers, meeting the SAM or MAM acute malnutrition case definitions described below with no medical complications and disability, and whose caregiver has granted consent to participate. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Eligible children are children aged 6-59 months of both sexes from households established permanently in the catchment area of the selected health posts or health centers, meeting the SAM or MAM acute malnutrition case definitions described above with no medical complications and disability, and whose caregiver has granted consent to participate.
Key inclusion criteria (6 listed)
- The child is between 6 and 23 months of age at inclusion.
- The mother must live in the study area from the time of inclusion.
- Mid-upper arm circumference (MUAC) <12.5 cm or WHZ <-2 or bilateral pitting edema.
- No serious medical complications.
- Positive appetite test.
Key exclusion criteria (3 listed)
- Congenital malformations that make anthropometric measurements impossible.
- Mother intends to leave the study area before six months.
- Presence of medical condition requiring referral for hospitalization.
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 |
|---|---|---|
| Ready-To-Use Therapeutic Food (RUTF)* SAM [MUAC <115mm or WHZ <-3 or oedema (+/++)] = Two 92g sachets RUTF/day (Approx. 1000 kcal/day). * MAM [MUAC 115mm<125mm or WHZ <-2] = One 92g sachet RUTF/day (Approx. 500 kcal/day). | Dietary supplement | Cases |
Primary outcome
Recovery rate
Time frame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
This indicator is defined as the number children who recovered from wasting, MAM and SAM according to national program criteria (WHZ>-2 and MUAC>=125mm and absence of bilateral edema for two consecutive visits, within 16 weeks of enrollment in the program) divided by the total number of treatment results recorded.
Weight gain
Time frame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Average weight change per month
MUAC gain
Time frame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Average change in MUAC per month
Duration of the treatment
Time frame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Defined as the average number of weeks spent on treatment (enrollment and discharge) in children 6-59 months of age at enrollment, according to health registers
Prevalence of relapse after discharge from the treatment
Time frame: at six months after the admission
This indicator is defined as the proportion of children with WHZ-score <-2 or MUAC <125 mm or bilateral edema six months after the admission
Number of RUTF delivered per child
Time frame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Average number of RUTF delivered per child (SAM/MAM)
Cost per child
Time frame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first
Average number of dollars that cost to recovery a child
4 secondary outcomes
Longitudinal prevalence of wasting
Time frame: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
Prevalence of child stunting
Time frame: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
Prevalence of child morbidity
Time frame: Up to 6 months, from date of enrolment until the date of last documented progression or date of death from any cause, whichever came first
Prevalence of readmission
Time frame: Up to 6 months, at 24 weeks after the admission
Results and safety
The study was stopped early (reason given: The sponsoring organization UNICEF-Venezuela with administrative control over the study decided to terminate it.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Malnutrition in Childhood
Not yet recruiting
The Relapse to Acute Malnutrition Prevention (RAMP) Trial
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
RecruitingPhase 4
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Severe Acute Malnutrition in Childhood, Pneumococcal Disease
Active, not recruiting
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
Severe Acute Malnutrition, Moderate Acute Malnutrition (MAM)
Not yet recruiting
Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food Compared to a Newly Formulated Lipid Optimized Ready To Use Therapeutic Food
Severe Acute Malnutrition in Childhood, Malnutrition, Child
Recruiting
The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis
Tuberculosis, Child Health
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.
Zulay Gonzalez, MSc principal investigator
UNICEF - Venezuela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Malnutrition in Childhood and Wasting, run by UNICEF - Venezuela at 1 site in Venezuela.
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 6 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: stopped early, as of the sponsor's last update on 10 May 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 Venezuela. 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 was stopped early (reason given: The sponsoring organization UNICEF-Venezuela with administrative control over the study decided to terminate it.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery rate (time frame: Up to 4 months, from date of inclusion in the program until the date of recovery or 16th week after inclusion in the program or date of death from any cause, whichever came first). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.