StuntingNCT05891457
Changes in Nerve Electro Physiologic Properties in Children Before and After Correction of Malnutrition
A study testing Nutritional Intervention in people with Stunting and Severe Acute Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
The goal of this clinical trail study is to measure neurophysiologic parameters to assess the effect of malnutrition on the peripheral nervous system and their response to treatment in three categories (SAM, severe wasting, and severe stunting) of childhood malnutrition. Read more about this study
- Who is it for?
- Ages 6 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Stunting, Severe Acute Malnutrition, Wasting
- What is being tested?
- Nutritional Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 May 2021to 30 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 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants who will give informed written consent
- Children aged between 6 months to 5 years of age
- Children whose length/height-for-age <-3 (Stunted), weight-for-length/height <-2 (Wasted), and weight-for-length/height z scores <-3 and/or mid upper arm circumference <11.5 cm, with or without nutritional edema
- Children whose length/height-for-age, weight-for-length/height, and weight-for-length/height z score will be ≥1
Who cannot join
- Participants with congenital anomalies, twins and multiple pregnancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in the Nerve Electro Physiologic Properties Before and After Correction of Malnutrition in Under-5 Children
The goal of this clinical trail study is to measure neurophysiologic parameters to assess the effect of malnutrition on the peripheral nervous system and their response to treatment in three categories (SAM, severe wasting, and severe stunting) of childhood malnutrition. 83 under-5 children from three categories of undernourished groups- severe stunting (n=30), Severe acute malnourished (n=22), wasting (n=31), and 45 age-matched healthy children from urban/peri-urban areas were enrolled.
SAm were provided with appropriate nutritional therapy/treatment that include supplementation of a high-calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation. Egg milk and micronutrient supplementation were for recovery from severe stunting. Wasted children were treated with suitable local nutritional management (NM), such as infant and young child feeding practices (IYCF), providing MNP and nutrition education. Wasted children with medical complications were treated with specialized therapeutic milk (F-75) and those without medical complications were treated with a suitable local Nutritional Management (NM) \& routine medicines to treat simple medical conditions at community nutrition center (CNC) with weekly follow up. At day 60 of intervention, children were again brought to icddr,b for a nerve conduction test.
Read the detailed description
The purpose of this study is to measure neurophysiologic parameters to assess the effect of malnutrition on peripheral nervous system and their response to treatment in three categories (SAM, severe wasting and severe stunting) of childhood malnutrition. The electrophysiological properties of peripheral nerves in malnourished under-5 children before and after correction of severe malnutrition were assed.
This is an exploratory study conducted in icddr,b, Dhaka, Bangladesh. 83 under-5 children from three categories of undernourished groups- severe stunting (length-for-age Z-scores <-3), SAM (weight-for-length Z-scores <-3, and/or mid-upper-arm circumference <11.5 cm, with or without nutritional edema) and wasting (weight-for-length Z-scores (WLZ) <-2) were enrolled. A total of 45 age-matched healthy children selected as controls. Participants were identified from urban/peri-urban areas of Dhaka city. After enrolment, participants were brought to icddr,b Dhaka Hospital and data on socio-economic status, weaning practice, morbidity, and dietary intake were collected. Nerve electro physiologic parameters assessed by motor (median, ulnar, fibular and tibial) and sensory (median, ulnar and sural) nerve conduction studies (NCS) on enrollment.
SAM were treated with appropriate nutritional therapy/treatment that included supplementation of high calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation. Egg-milk and micronutrient supplementation were provided for 2 months for recovery from severe stunting (following standard guidelines for facility based management and recently conducted community based nutrition intervention studies). As per national guidelines, children suffering from severe wasting with medical complications were treated with specialized therapeutic milks (F-75) and those without medical complications treated with a suitable local Nutritional Management (NM) \& routine medicines to treat simple medical conditions at community nutrition center (CNC) with weekly follow up. Children were monitored in the community for 2 months. Monthly anthropometry had been done. On day 60 or 2 months of intervention, children with weight-for-length/height Z-scores ≥-1 and MUAC >115 mm were again brought to icddr, b for nerve conduction test.
- Conditions
- Stunting, Severe Acute Malnutrition, Wasting
- Being tested
- Nutritional Intervention
- Keywords
- Malnutrition, Nerve Conduction
- Medical subject headings
- Growth Disorders, Severe Acute Malnutrition, Cachexia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionCombination product
- Severe acute malnourished children were provided with appropriate nutritional therapy/treatment that include supplementation of a high-calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation.
- Egg milk and micronutrient supplementation for recovery from severe stunting following standard guidelines for facility based management and recently conducted community based nutrition intervention studies.
- Wasted children were treated with suitable local nutritional management (NM), such as infant and young child feeding practices (IYCF), providing MNP and nutrition education.
| Study group | Role | What they receive |
|---|---|---|
| Malnourished children | Experimental | * Severe Stunting (length/height-for-age Z-scores <-3SD)
* Severe Acute Malnutrition (weight-for-length/height Z-scores <-3SD, and/or mid-upper-arm circumference <11.5 cm, with or without nutritional edema)
* Wasting (weight-for-length/height Z-scores<-3SD) Receives: Combination Product: Nutritional Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compound muscle action potential (CMAP) amplitude
Motor nerve compound muscle action potential (CMAP) amplitude is measured from baseline to peak amplitude for all the stimulation sites and expressed in millivolts (mV)
Measured: 60 days
Motor nerve conduction velocity
Motor nerve conduction velocity is measured by the distance between the distal and proximal stimulation sites, divided by the difference in latency, and expressed in meters per second (m/s)
Measured: 60 Days
Motor nerve corrected distal latency
Motor nerve corrected distal latency is measured from the onset (or rise of the negative deflection) of the compound muscle action potential and expressed in milliseconds (ms)
Measured: 60 Days
Sensory nerve action potential (SNAP) amplitude
Sensory nerve action potential (SNAP) amplitude is measured from baseline-to-peak amplitude at the distal stimulation site and expressed in microvolts (μV)
Measured: 60 Days
Sensory nerve conduction velocity
Sensory nerve conduction velocity is measured by the distance between the distal and proximal stimulation sites, divided by the difference in latency, and expressed in meters per second (m/s)
Measured: 60 Days
Sensory nerve corrected distal latency
Sensory nerve corrected distal latency is measured from the onset (or rise of the negative deflection) of the compound muscle action potential and expressed in milliseconds (ms).
Measured: 60 Days
Secondary outcomes (6)
Changes in weight
Changes in weight measured in kg
Measured: 60 Days
Changes in height
Changes in height measured in cm
Measured: 60 Days
Changes in Mid Upper Arm Circumference (MUAC) for SAM
Changes in Mid Upper Arm Circumference (MUAC) measured in mm or cm
Measured: 60 Days
Changes in weight-for-height Z score for SAM
Changes in weight-for-height Z score measured in points
Measured: 60 Days
Changes in weight-for-height Z score for Wasted
Changes in weight-for-height Z score measured in points
Measured: 60 Days
Changes in height-for-age Z score for Stunted
Changes in height-for-age Z score measured in points
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 May 2021
- Primary completion30 Jun 2022
- Study completion30 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 StuntingStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891457
- Sponsor's protocol ID
- PR-21013
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naila NN, Hossain MS, Alam A, Das S, Karmakar G, Mahfuz M, Ahmed T, Islam B. Nutritional Intervention Improves Nerve Conduction in Malnourished Children Under 5 Years of Age. Acta Paediatr. 2025 Nov;114(11):2864-2873. doi: 10.1111/apa.70179. Epub 2025 Jun 18.
PubMed 40530465
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in the Nerve Electro Physiologic Properties Before and After Correction of Malnutrition in Under-5 Children
- ClinicalTrials.gov ID
- NCT05891457
- Acronym / sponsor ID
- PR-21013
- Conditions
- Stunting, Severe Acute Malnutrition, Wasting
- Keywords
- Malnutrition, Nerve Conduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Swedish International Development Cooperation Agency (SIDA)
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Jun 2023 (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.
The goal of this clinical trail study is to measure neurophysiologic parameters to assess the effect of malnutrition on the peripheral nervous system and their response to treatment in three categories (SAM, severe wasting, and severe stunting) of childhood malnutrition. 83 under-5 children from three categories of undernourished groups- severe stunting (n=30), Severe acute malnourished (n=22), wasting (n=31), and 45 age-matched healthy children from urban/peri-urban areas were enrolled.
SAm were provided with appropriate nutritional therapy/treatment that include supplementation of a high-calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation. Egg milk and micronutrient supplementation were for recovery from severe stunting. Wasted children were treated with suitable local nutritional management (NM), such as infant and young child feeding practices (IYCF), providing MNP and nutrition education. Wasted children with medical complications were treated with specialized therapeutic milk (F-75) and those without medical complications were treated with a suitable local Nutritional Management (NM) \& routine medicines to treat simple medical conditions at community nutrition center (CNC) with weekly follow up. At day 60 of intervention, children were again brought to icddr,b for a nerve conduction test.
Detailed description
The purpose of this study is to measure neurophysiologic parameters to assess the effect of malnutrition on peripheral nervous system and their response to treatment in three categories (SAM, severe wasting and severe stunting) of childhood malnutrition. The electrophysiological properties of peripheral nerves in malnourished under-5 children before and after correction of severe malnutrition were assed.
This is an exploratory study conducted in icddr,b, Dhaka, Bangladesh. 83 under-5 children from three categories of undernourished groups- severe stunting (length-for-age Z-scores <-3), SAM (weight-for-length Z-scores <-3, and/or mid-upper-arm circumference <11.5 cm, with or without nutritional edema) and wasting (weight-for-length Z-scores (WLZ) <-2) were enrolled. A total of 45 age-matched healthy children selected as controls. Participants were identified from urban/peri-urban areas of Dhaka city. After enrolment, participants were brought to icddr,b Dhaka Hospital and data on socio-economic status, weaning practice, morbidity, and dietary intake were collected. Nerve electro physiologic parameters assessed by motor (median, ulnar, fibular and tibial) and sensory (median, ulnar and sural) nerve conduction studies (NCS) on enrollment.
SAM were treated with appropriate nutritional therapy/treatment that included supplementation of high calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation. Egg-milk and micronutrient supplementation were provided for 2 months for recovery from severe stunting (following standard guidelines for facility based management and recently conducted community based nutrition intervention studies). As per national guidelines, children suffering from severe wasting with medical complications were treated with specialized therapeutic milks (F-75) and those without medical complications treated with a suitable local Nutritional Management (NM) \& routine medicines to treat simple medical conditions at community nutrition center (CNC) with weekly follow up. Children were monitored in the community for 2 months. Monthly anthropometry had been done. On day 60 or 2 months of intervention, children with weight-for-length/height Z-scores ≥-1 and MUAC >115 mm were again brought to icddr, b for nerve conduction test.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malnourished children | Experimental | Combination Product: Nutritional Intervention* Severe Stunting (length/height-for-age Z-scores <-3SD) * Severe Acute Malnutrition (weight-for-length/height Z-scores <-3SD, and/or mid-upper-arm circumference <11.5 cm, with or without nutritional edema) * Wasting (weight-for-length/height Z-scores<-3SD) |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants who will give informed written consent
- Children aged between 6 months to 5 years of age
- Children whose length/height-for-age <-3 (Stunted), weight-for-length/height <-2 (Wasted), and weight-for-length/height z scores <-3 and/or mid upper arm circumference <11.5 cm, with or without nutritional edema
- Children whose length/height-for-age, weight-for-length/height, and weight-for-length/height z score will be ≥1
Key exclusion criteria (1 listed)
- Participants with congenital anomalies, twins and multiple pregnancies
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 Intervention* Severe acute malnourished children were provided with appropriate nutritional therapy/treatment that include supplementation of a high-calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation. * Egg milk and micronutrient supplementation for recovery from severe stunting following standard guidelines for facility based management and recently conducted community based nutrition intervention studies. * Wasted children were treated with suitable local nutritional management (NM), such as infant and young child feeding practices (IYCF), providing MNP and nutrition education. | Combination product | Malnourished children |
Primary outcome
Compound muscle action potential (CMAP) amplitude
Time frame: 60 days
Motor nerve compound muscle action potential (CMAP) amplitude is measured from baseline to peak amplitude for all the stimulation sites and expressed in millivolts (mV)
Motor nerve conduction velocity
Time frame: 60 Days
Motor nerve conduction velocity is measured by the distance between the distal and proximal stimulation sites, divided by the difference in latency, and expressed in meters per second (m/s)
Motor nerve corrected distal latency
Time frame: 60 Days
Motor nerve corrected distal latency is measured from the onset (or rise of the negative deflection) of the compound muscle action potential and expressed in milliseconds (ms)
Sensory nerve action potential (SNAP) amplitude
Time frame: 60 Days
Sensory nerve action potential (SNAP) amplitude is measured from baseline-to-peak amplitude at the distal stimulation site and expressed in microvolts (μV)
Sensory nerve conduction velocity
Time frame: 60 Days
Sensory nerve conduction velocity is measured by the distance between the distal and proximal stimulation sites, divided by the difference in latency, and expressed in meters per second (m/s)
Sensory nerve corrected distal latency
Time frame: 60 Days
Sensory nerve corrected distal latency is measured from the onset (or rise of the negative deflection) of the compound muscle action potential and expressed in milliseconds (ms).
6 secondary outcomes
Changes in weight
Time frame: 60 Days
Changes in height
Time frame: 60 Days
Changes in Mid Upper Arm Circumference (MUAC) for SAM
Time frame: 60 Days
Changes in weight-for-height Z score for SAM
Time frame: 60 Days
Changes in weight-for-height Z score for Wasted
Time frame: 60 Days
Changes in height-for-age Z score for Stunted
Time frame: 60 Days
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 7 Jun 2023.
- Derived from this study: PubMed 40530465Naila NN, Hossain MS, Alam A, Das S, Karmakar G, Mahfuz M, Ahmed T, Islam B. Nutritional Intervention Improves Nerve Conduction in Malnourished Children Under 5 Years of Age. Acta Paediatr. 2025 Nov;114(11):2864-2873. doi: 10.1111/apa.70179. Epub 2025 Jun 18.
- 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.
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 Intervention in people with Stunting and Severe Acute Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 1 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 7 Jun 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 Bangladesh. 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?
Compound muscle action potential (CMAP) amplitude (time frame: 60 days). The study lists 6 primary outcomes in all. 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 NCT05891457, 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 7 Jun 2023.