Malnutrition; ModeratePhase 4NCT04323059
Effectiveness, Tolerability and Safety of Three Formulations in Underfives With Moderate Acute Malnutrition
A Phase 4 study testing Standardized milk-based formulation in people with Malnutrition; Moderate, run by Dr. Ekong E. Udoh at 3 sites in Nigeria.
Trial summary
This is a randomized clinical trial aimed at evaluating the effectiveness, tolerability and safety of standardized milk-based formulation, standardized non-milk based formulation and a hospital-based formulation in the management of children aged 6 - 59 months with moderate acute malnutrition. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malnutrition; Moderate
- What is being tested?
- Standardized milk-based formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesNigeria
- Study dates
- Apr 2020to Nov 2020
- Phase
- Phase 4
- 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
- Children aged 6 - 59 months with moderate acute malnutrition (weight-for-height between -2 and -3 Z scores or mid upper arm circumference of 11.5 cm - 12.5 cm).
- Children whose parents/guardian consent to their participation and agree to bring the children/wards to the health facility throughout the period of the study.
Who cannot join
- Children with chronic illnesses that may affect growth {(cardiac disease, renal disease, tuberculosis (chronic cough, history of contact with an adult with chronic cough, poor growth, chest infection not responding to antibiotics) liver disease, HIV/AIDS}
- Children with feeding difficulties eg. Gastroesophageal reflux diseases, cleft palate
- Children with diarrhoea
- Children with neurological diseases eg. Cerebral palsy
- Children less than 6 months or more 59 months of age
Trial locations and contacts
3 sites in 1 country.
Nigeria3 sites
Primary Health Centre, Okpoediuse
Ibiono Ibom, Akwa Ibom State
Edo Asuquo, +234(0)7064559257
Anietie Ekwere, +234(7)089721411
Primary Health Centre, Adadiah
Uruan, Akwa Ibom State
Christiana F Ekpeyong, +234(0)8067685745
Okon Asuquo, +234(0)7063384541
Primary Health centre, Mbak-Etoi
Uyo, Akwa Ibom State
Eneawan Edem, +234(0)8028457047
Victoria Usen, +234(0)7030227955
About this study
Official title: Effectiveness, Tolerability and Safety of Standardized Milk-based, Standardized Non-milk Based and Hospital-based Formulations in the Management of Moderate Acute Malnutrition in Underfive Children: A Randomized Clinical Trial
This is a randomized clinical trial aimed at evaluating the effectiveness, tolerability and safety of standardized milk-based formulation, standardized non-milk based formulation and a hospital-based formulation in the management of children aged 6 - 59 months with moderate acute malnutrition. Eligible children will be randomized into one of the three intervention arms and given supplementary doses of the formulations at 50% of their daily caloric requirement for a period of four months based on the group of their assignment. The remainder will be obtained from their regular family diets. The clinical features, anthropometric measurements and laboratory parameters of the children will be assessed at baseline. The children will be followed up on two weekly basis for a period of four months during which further clinical assessment, anthropometric measurements and laboratory evaluations will be performed. The outcome measures will be determined based on "per protocol analysis".
Read the detailed description
Childhood malnutrition is presently a leading cause of underfive morbidity and mortality globally. The impact of the condition is most severe in the first 1000 days of life with resultant impairment in physical, neurologic, immunologic and metabolic development.
Undernutrition, the commoner form of childhood malnutrition, is usually classified as underweight (weight-for-age Z score < -2), stunting (height-for-age Z score <-2), wasting (weight-for-height Z score < -2) or edematous malnutrition (kwashiorkor) in relation to the World Health Organization standard reference values for age and sex. It is further sub-classified into severe acute malnutrition (SAM) wherein z score is <-3 and moderate acute malnutrition (MAM) wherein z score is between -2 and -3.(1) MAM accounts for about 70.0% of all malnutrition-related childhood deaths.
Children with MAM are currently managed using community-based approach. This approach entails early detection and treatment of children with MAM in the community, timely referral to inpatient care for those that progress to SAM or develop complications, and subsequent follow up in the community at discharge. MAM is usually managed by nutrition education of the caregivers on preparation of nutritious, palatable and culturally acceptable food from locally available food stuffs like banana porridge or corn gruel fortified with legume (mashed groundnut or soya bean), crayfish, palm oil, powdered milk and vegetables. The second strategy is by Ready-to-use therapeutic foods (RUTFs). (2) The main drawback of the RUTFs is that they are usually provided by external donor agencies and as such, not always available in settings where childhood malnutrition is endemic. Children treated with RUTFs are therefore at risk of progressing to SAM or dying when the formulations are no longer available. There is currently no consensus on the appropriate nutritional formulation for community-based management of MAM in children in endemic regions. It is therefore imperative to evaluate the effect of readily available formulations that are comparable to the RUTFs in community-based management of childhood MAM in endemic regions. (3) The standardized milk-based formulation (SMBF), the standardized non milk-based formulation (SNMBF) and the hospital-based formulation (HBF) are examples of formulations that are readily available in the country. The SMBF consists of maize and is rich in methionine, the SNMBF consists of maize and soybeans, and is rich in methionine and lysine while the HBF consist of a combination of maize, milk and soybeans. The nutrient composition of the above-mentioned formulations is similar to that of the RUTFs, making them suitable for community-based management of MAM. However, no clinical trial has so far been conducted to evaluate their effect in managing underfive children with MAM. The cost effectiveness of the various formulations will also be assessed.
- Conditions
- Malnutrition; Moderate
- Being tested
- Standardized milk-based formulation
- Keywords
- Nutrition, Formulations, Moderate, Malnutrition, Underfives
- Medical subject headings
- Malnutrition, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized milk-based formulationDietary supplement
Also called Standardized non-milk based formulation, Hospital-based formulation
Nutritional formulations prepared from locally available food stuffs for reversing childhood malnutrition
| Study group | Role | What they receive |
|---|---|---|
| Standardized milk-based formulation | Experimental | Formulation of maize with milk that is rich in methionine Receives: Dietary Supplement: Standardized milk-based formulation |
| Standardized non-milk based formulation | Experimental | Formulation of maize with soybeans that is rich in methionine and lysine Receives: Dietary Supplement: Standardized milk-based formulation |
| Hospital-based formulation | Active comparator | Formulation of maize, milk and soybeans Receives: Dietary Supplement: Standardized milk-based formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight-for-height
Improvement in weight-for-height at two weekly intervals
Measured: Four months
Secondary outcomes (2)
Recovery from moderate acute malnutrition
Proportion of children whose weight-for-height z score improved from <-2 to ≥ 2
Measured: Four month
Adverse events
The number of children that develop and undesirable gastrointestinal or extraintestinal disorder
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study startApr 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malnutrition; ModerateStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study participants will be randomized into three different intervention groups. Based on the group of assignment, the participants will receive either the standardized milk-based formulation, the standardized non-milk based formulation or the hospital-based formulation.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Ekong E. Udoh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Ekong E. Udoh, University of Uyo Teaching Hospital
- Investigators
- Ekong E Udoh, FWACPaed, Principal investigator, University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, NigeriaSunday B Adesina, FWACPaed, Study director, University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, NigeriaBlessing N Nwazuluoke, BSc, Study chair, University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323059
- Sponsor's protocol ID
- UUTH/AD/S/96/VOL.XXI/341
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will be made available to other researchers by the Principal Investigator on request.
Publications
Seetharaman N, Chacko TV, Shankar SLR, Matthew AC. Measuring malnutrition - the roles of Z scores and the composite index of anthropometric failure. Indian Journal of Community Medicine. 2007; 32 (1): 35-39.
Vijay DW, Bhawesh RD. Ready to use therapeutic food (RUTF): An overview.. Advances in life Sciences and Health. 2015; 2 (1): 1-15.
Choudhury N, Ahmed T, Hossain MI, Islam MM, Sarker SA, Zeilani M, Clemens JD. Ready-to-Use Therapeutic Food Made From Locally Available Food Ingredients Is Well Accepted by Children Having Severe Acute Malnutrition in Bangladesh. Food Nutr Bull. 2018 Mar;39(1):116-126. doi: 10.1177/0379572117743929. Epub 2017 Dec 19.
PubMed 29258336
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Tolerability and Safety of Standardized Milk-based, Standardized Non-milk Based and Hospital-based Formulations in the Management of Moderate Acute Malnutrition in Underfive Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04323059
- Acronym / sponsor ID
- UUTH/AD/S/96/VOL.XXI/341
- Conditions
- Malnutrition; Moderate
- Keywords
- Nutrition, Formulations, Moderate, Malnutrition, Underfives
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr. Ekong E. UdohUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 26 Mar 2020 (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.
This is a randomized clinical trial aimed at evaluating the effectiveness, tolerability and safety of standardized milk-based formulation, standardized non-milk based formulation and a hospital-based formulation in the management of children aged 6 - 59 months with moderate acute malnutrition. Eligible children will be randomized into one of the three intervention arms and given supplementary doses of the formulations at 50% of their daily caloric requirement for a period of four months based on the group of their assignment. The remainder will be obtained from their regular family diets. The clinical features, anthropometric measurements and laboratory parameters of the children will be assessed at baseline. The children will be followed up on two weekly basis for a period of four months during which further clinical assessment, anthropometric measurements and laboratory evaluations will be performed. The outcome measures will be determined based on "per protocol analysis".
Detailed description
Childhood malnutrition is presently a leading cause of underfive morbidity and mortality globally. The impact of the condition is most severe in the first 1000 days of life with resultant impairment in physical, neurologic, immunologic and metabolic development.
Undernutrition, the commoner form of childhood malnutrition, is usually classified as underweight (weight-for-age Z score < -2), stunting (height-for-age Z score <-2), wasting (weight-for-height Z score < -2) or edematous malnutrition (kwashiorkor) in relation to the World Health Organization standard reference values for age and sex. It is further sub-classified into severe acute malnutrition (SAM) wherein z score is <-3 and moderate acute malnutrition (MAM) wherein z score is between -2 and -3.(1) MAM accounts for about 70.0% of all malnutrition-related childhood deaths.
Children with MAM are currently managed using community-based approach. This approach entails early detection and treatment of children with MAM in the community, timely referral to inpatient care for those that progress to SAM or develop complications, and subsequent follow up in the community at discharge. MAM is usually managed by nutrition education of the caregivers on preparation of nutritious, palatable and culturally acceptable food from locally available food stuffs like banana porridge or corn gruel fortified with legume (mashed groundnut or soya bean), crayfish, palm oil, powdered milk and vegetables. The second strategy is by Ready-to-use therapeutic foods (RUTFs). (2) The main drawback of the RUTFs is that they are usually provided by external donor agencies and as such, not always available in settings where childhood malnutrition is endemic. Children treated with RUTFs are therefore at risk of progressing to SAM or dying when the formulations are no longer available. There is currently no consensus on the appropriate nutritional formulation for community-based management of MAM in children in endemic regions. It is therefore imperative to evaluate the effect of readily available formulations that are comparable to the RUTFs in community-based management of childhood MAM in endemic regions. (3) The standardized milk-based formulation (SMBF), the standardized non milk-based formulation (SNMBF) and the hospital-based formulation (HBF) are examples of formulations that are readily available in the country. The SMBF consists of maize and is rich in methionine, the SNMBF consists of maize and soybeans, and is rich in methionine and lysine while the HBF consist of a combination of maize, milk and soybeans. The nutrient composition of the above-mentioned formulations is similar to that of the RUTFs, making them suitable for community-based management of MAM. However, no clinical trial has so far been conducted to evaluate their effect in managing underfive children with MAM. The cost effectiveness of the various formulations will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study participants will be randomized into three different intervention groups. Based on the group of assignment, the participants will receive either the standardized milk-based formulation, the standardized non-milk based formulation or the hospital-based formulation.
| Arm | Type | Receives |
|---|---|---|
| Standardized milk-based formulation | Experimental | Dietary Supplement: Standardized milk-based formulationFormulation of maize with milk that is rich in methionine |
| Standardized non-milk based formulation | Experimental | Dietary Supplement: Standardized milk-based formulationFormulation of maize with soybeans that is rich in methionine and lysine |
| Hospital-based formulation | Active comparator | Dietary Supplement: Standardized milk-based formulationFormulation of maize, milk and soybeans |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 6 - 59 months with moderate acute malnutrition (weight-for-height between -2 and -3 Z scores or mid upper arm circumference of 11.5 cm - 12.5 cm).
- Children whose parents/guardian consent to their participation and agree to bring the children/wards to the health facility throughout the period of the study.
Key exclusion criteria (5 listed)
- Children with chronic illnesses that may affect growth {(cardiac disease, renal disease, tuberculosis (chronic cough, history of contact with an adult with chronic cough, poor growth, chest infection not responding to antibiotics) liver disease, HIV/AIDS}
- Children with feeding difficulties eg. Gastroesophageal reflux diseases, cleft palate
- Children with diarrhoea
- Children with neurological diseases eg. Cerebral palsy
- Children less than 6 months or more 59 months of age
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 |
|---|---|---|
| Standardized milk-based formulationAlso: Standardized non-milk based formulation, Hospital-based formulationNutritional formulations prepared from locally available food stuffs for reversing childhood malnutrition | Dietary supplement | Hospital-based formulation, Standardized milk-based formulation, Standardized non-milk based formulation |
Primary outcome
weight-for-height
Time frame: Four months
Improvement in weight-for-height at two weekly intervals
2 secondary outcomes
Recovery from moderate acute malnutrition
Time frame: Four month
Adverse events
Time frame: Four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- BackgroundSeetharaman N, Chacko TV, Shankar SLR, Matthew AC. Measuring malnutrition - the roles of Z scores and the composite index of anthropometric failure. Indian Journal of Community Medicine. 2007; 32 (1): 35-39.
- BackgroundVijay DW, Bhawesh RD. Ready to use therapeutic food (RUTF): An overview.. Advances in life Sciences and Health. 2015; 2 (1): 1-15.
- Background: PubMed 29258336Choudhury N, Ahmed T, Hossain MI, Islam MM, Sarker SA, Zeilani M, Clemens JD. Ready-to-Use Therapeutic Food Made From Locally Available Food Ingredients Is Well Accepted by Children Having Severe Acute Malnutrition in Bangladesh. Food Nutr Bull. 2018 Mar;39(1):116-126. doi: 10.1177/0379572117743929. Epub 2017 Dec 19.
- Individual participant dataSharing planned: Yes. Individual patient data will be made available to other researchers by the Principal Investigator on request.
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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.
Ekong E Udoh, FWACPaed principal investigator
University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria
Sunday B Adesina, FWACPaed study director
University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria
Blessing N Nwazuluoke, BSc study chair
University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standardized milk-based formulation in people with Malnutrition; Moderate, run by Dr. Ekong E. Udoh at 3 sites in Nigeria.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nigeria. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekong E Udoh, FWACPaed (+234(0)38355559, rejoicerejoice2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight-for-height (time frame: Four months). 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 NCT04323059, which also lists 3 linked publications.
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 30 Mar 2020.