Severe Acute MalnutritionNCT06545240
Performance of Mid-Upper Arm Circumference for Detection of Severe Acute Malnutrition in Indonesian Under-Fives
An observational study of Severe Acute Malnutrition, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
WHO recommends 11.5 cm as a cut-off point of Mid-Upper Arm Circumference (MUAC) to detect and/or diagnose severe acute malnutrition (SAM) in under-five. MUAC is practical and useful, especially in area with limited facilities which has no standardized scale and infantometer. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- Mid-upper arm circumference
- How many people
- 421 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 Jan 2020to 29 Feb 2020
- 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
- Healthy volunteers accepted
- Child
Study population: This study was conducted in the largest primary community health care facility in Cengkareng Jakarta and have 29.110 registered under-fives in its service area.
Who may be able to join
- under-fives that 6-59 months-old
Who cannot join
- ascites
- edema
- hydrocephalus
- tumor or oncologic diseases
- organomegaly
- uncooperative during measurement
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Puskesmas Cengkareng
Jakarta, DKI Jakarta, 11730
RSUPN Dr Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 10440
About this study
WHO recommends 11.5 cm as a cut-off point of Mid-Upper Arm Circumference (MUAC) to detect and/or diagnose severe acute malnutrition (SAM) in under-five. MUAC is practical and useful, especially in area with limited facilities which has no standardized scale and infantometer. However, several studies showed that this cut-off need to be evaluated as it has modest detection rate for SAM. This study aims to evaluate diagnostic value of MUAC with 11.5 cm cut-off compared to WHZ as gold standard to identify SAM. The sensitivity, specificity, positive and negative predictive value of MUAC with 11.5 cm as a standard cut-off will be evaluated.
This study also aim to find new cut-off value that may offer better diagnostic performance. The main research questions were:
What is the diagnostic accuracy of Mid-Upper Arm Circumference (MUAC) compared to the Weight for Height Z Score (WHZ) in identifying SAM in children, and what is the optimal MUAC cut-off value for enhanced diagnostic performance?
- Conditions
- Severe Acute Malnutrition
- Being tested
- Mid-upper arm circumference
- Keywords
- mid-upper arm circumference, sensitivity, severe acute malnutrition, specificity, WHZ index
- Medical subject headings
- Severe Acute Malnutrition, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid-upper arm circumferenceDiagnostic test
Also called Weight measurement, Length and height measurement
Mid-upper arm circumference was taken using non-stretchable band SECA 202
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of MUAC in diagnosing SAM compare to WHZ-index
To evaluate sensitivity, specificity, positive and negative predictive value of MUAC
Measured: 2 months
Secondary outcomes (1)
Finding new cut off value that offer better diagnostic performance using ROC
To compare sensitivity, specificity, positive and negative predictive value of MUAC with 11.5 cm as standard cut off and to new cut-off value that may offer better diagnostic performance
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2020
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klara Yuliarti, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545240
- Sponsor's protocol ID
- 19-12-1452
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Mid-Upper Arm Circumference for Detection of Severe Acute Malnutrition in Indonesian Under-Fives
- ClinicalTrials.gov ID
- NCT06545240
- Acronym / sponsor ID
- 19-12-1452
- Conditions
- Severe Acute Malnutrition
- Keywords
- mid-upper arm circumference, sensitivity, severe acute malnutrition, specificity, WHZ index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 9 Aug 2024 (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.
WHO recommends 11.5 cm as a cut-off point of Mid-Upper Arm Circumference (MUAC) to detect and/or diagnose severe acute malnutrition (SAM) in under-five. MUAC is practical and useful, especially in area with limited facilities which has no standardized scale and infantometer. However, several studies showed that this cut-off need to be evaluated as it has modest detection rate for SAM. This study aims to evaluate diagnostic value of MUAC with 11.5 cm cut-off compared to WHZ as gold standard to identify SAM. The sensitivity, specificity, positive and negative predictive value of MUAC with 11.5 cm as a standard cut-off will be evaluated.
This study also aim to find new cut-off value that may offer better diagnostic performance. The main research questions were:
What is the diagnostic accuracy of Mid-Upper Arm Circumference (MUAC) compared to the Weight for Height Z Score (WHZ) in identifying SAM in children, and what is the optimal MUAC cut-off value for enhanced diagnostic performance?
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study was conducted in the largest primary community health care facility in Cengkareng Jakarta and have 29.110 registered under-fives in its service area.
Key inclusion criteria (1 listed)
- under-fives that 6-59 months-old
Key exclusion criteria (6 listed)
- ascites
- edema
- hydrocephalus
- tumor or oncologic diseases
- organomegaly
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 |
|---|---|---|
| Mid-upper arm circumferenceAlso: Weight measurement, Length and height measurementMid-upper arm circumference was taken using non-stretchable band SECA 202 | Diagnostic test | – |
Primary outcome
Diagnostic value of MUAC in diagnosing SAM compare to WHZ-index
Time frame: 2 months
To evaluate sensitivity, specificity, positive and negative predictive value of MUAC
1 secondary outcome
Finding new cut off value that offer better diagnostic performance using ROC
Time frame: 2 months
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 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Malnutrition, run by Universitas Indonesia at 2 sites in Indonesia.
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 1 inclusion and 6 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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?
Diagnostic value of MUAC in diagnosing SAM compare to WHZ-index (time frame: 2 months). 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 9 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.