Malnutrition, ChildNCT04045249
Comparison of Different Feeding Protocols for the Treatment of Acute Malnutrition
A study testing Home based food in people with Malnutrition, Child, run by Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab at 1 site in Pakistan.
Trial summary
Though malnutrition is prevalent worldwide but its situation is alarming in low- and middle-income countries. Pakistan has also been facing an alarming situation of prevailing severe malnutrition. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malnutrition, Child
- What is being tested?
- Home based food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2018to 25 Apr 2019
- 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 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6-59 months with MUAC <11.5cm and Weight for Height Z score < -3SD
- Having good appetite, alert and clinically well
Who cannot join
- WHZ score - 4 SD
- MUAC < 8 cm
- Secondary malnutrition diagnosed by a gastroenterologist and dietitian
- Family History
- Birth Anomolies
- Any hidden/ asymptomatic health conditions
Show all 14Show fewer
- Any patient coming from out of city (Lahore)
- Anorexia
- High fever (>104 F)
- Severe pallor
- Severe dehydration
- Lower respiratory tract infection
- Bipedal edema
- Visible severe wasting
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Children's Hospital & The Institute of Child Health
Lahore, Punjab Province, 54000
About this study
Official title: Comparison Between Different Feeding Protocols and Existing Protocol for the Treatment of Acute Malnutrition (A Cluster Randomized Controlled Clinical Trial)
Though malnutrition is prevalent worldwide but its situation is alarming in low- and middle-income countries. Pakistan has also been facing an alarming situation of prevailing severe malnutrition. Malnutrition in its any form costs a huge intolerable burden not only on national health care system, but also on social and economic fabric of the nation. The current management of severe malnutrition is based on World Health Organization (WHO) guidelines and protocols which has been evolved from expert opinions and observational studies. The principles of these protocols have emerged from emergency settings and converting these protocols for developing countries where severe malnutrition, a routine burden is a critical challenge. In the absence of standard protocols for the treatment of uncomplicated severe malnutrition in non-emergency settings it is important to test and optimize different approaches to treat severely acute malnutrition (SAM). It is hypothesized that by optimizing, adapting and implementing time oriented and resource intensive approaches, a huge burden of high cost of RUTF may be reduced. While RUTF may be utilized to treat SAM children in emergency settings, it is not a substitute of local household foods. Therefore, a pilot study has been conducted to compare the various treatment protocols for malnourished children. We specifically hypothesized that a reduced dose of RUTF for reduced duration, combined with age-appropriate food intake from locally available resources can treat uncomplicated SAM children cost effectively as compared to standard national Community Management of Acute Malnutrition (CMAM) protocol currently implemented in Punjab, Pakistan.
Read the detailed description
Malnutrition signifies to inadequacies, immoderations or imbalances in an individual's consumption of nutrients or energy. The word malnutrition covers both under and over-nutrition. Undernutrition manifest in two different ways acute and chronic malnutrition. The acute malnutrition includes wasting while chronic malnutrition includes stunting. The situation of malnutrition has been perplexed in Pakistan in recent years and according to National Nutrition Survey (2018) rates of wasting are alarmingly high. Also, Pakistan ranks at 2nd position for infant and child mortality. The standard treatment of uncomplicated SAM in Pakistan often utilizes prolonged use of therapeutic food (RUTF), and after discharge results in high rates of relapse(official data from department of Health doesn't support this statement, according to them there is low rate of relapse). The present pilot study was conducted with the objective to find cost effective treatment protocols for treatment of uncomplicated SAM children. The study was conducted at The Children's Hospital and Institute of Child Health, Lahore in Out Patient Therapeutic Program (OTP) of Preventive Pediatrics Department. The children diagnosed with SAM aged 6-59 months without any specific gender preference were recruited. Weight, height and MUAC were measured at the time of enrolment in the study and Weight for Height (WHZ), Weight for Age (WAZ), Height for Age (HAZ) standard deviation (SD) Z scores and weight velocity was calculated for baseline. For current pilot study SAM children were grouped into 3 clusters. First, 30 children were grouped in 1st cluster, next 30 in 2nd cluster and further next 30 in 3rd cluster. Children in 1st cluster were treated as per standard CMAM protocols. Children in this cluster were provided RUTF as per admission weight of child until they attain 11.5cm MUAC or >-3SD WHZ. The children in the 2nd group (1st intervention group) were initially provided RUTF until they attain MUAC 11cm. After this, children were provided 50% of their required daily calories intake by RUTF and 50% of the calories were provided by the home-based food. The children in the 3rd group (2nd intervention group) were initially provided RUTF until they attain MUAC 11 cm. After this, children were provided their 100% caloric requirement from home-based food along with micronutrients sachets (MMS). The discharge criteria for control group was according to the existing CMAM guidelines that is MUAC > 11.5 cm. The discharge criteria for 2nd \& 3rd group was MUAC > 12.5 cm and WHZ > -2SD score. Follow-up home visits of all children were done according to a predefined protocol. During follow-up the control and intervention groups underwent weekly anthropometric measurements. Follow up of the study participants of each group was continued for one month. Growth rate, recovery rate, mortality rate, relapse frequency and duration of recovery were calculated for each group.
- Conditions
- Malnutrition, Child
- Being tested
- Home based food
- Keywords
- Malnutrition, RUTF, Children, Home base food
- Medical subject headings
- Child Nutrition Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based foodDietary supplement
Home based food is compare able to RUTF
| Study group | Role | What they receive |
|---|---|---|
| 1st Group | No intervention | Children were treated as per standard CMAM protocols; provided RUTF until MUAC reaches 11.5 cm |
| 2nd Group (1st Intervention group) | Experimental | Children were initially provided RUTF until MUAC reach 11 cm then 50 % calories were provided from RUTF and 50% calories from home based food Receives: Dietary Supplement: Home based food |
| 3rd Group (2nd Intervention) | Experimental | Children were initially provided RUTF until MUAC reach 11 cm then 100 % calories provided from home based food Receives: Dietary Supplement: Home based food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth velocity
Weight in Kg
Measured: 3 months
Growth velocity
Height in cm
Measured: 3 months
Growth velocity
Mid Upper Arm Circumference (MUAC) in cm
Measured: 3 months
Duration of recovery from SAM
Time required each child to reach MUAC > 11.5
Measured: 3 months
Rate of relapse
Number of children relapsed during the trial
Measured: 3 months
Rate of mortality
Number of children dying during trial
Measured: 3 months
Secondary outcomes (3)
Rate of recovery from Moderate Acute Malnutrition in 1st group
Proportion of children who reach MUAC > 12.5 cm
Measured: 3 months
Number of children having diarrhoea and acute respiratory infection during trial
Measured: 3 months
Number of children not coming for follow up visits due to any reason
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start10 Dec 2018
- Primary completion25 Apr 2019
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnutrition, ChildStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study involved 3 arms; 1st arm was treated as per standard protocol. 2nd arm was provided half calories from RUTF and half from home based food, 3rd arm was provided home based food along with MMS
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Zahra Khan, Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab
- Investigators
- Zahra Khan, PhD, Principal investigator, IRMNCH & Nutrition Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045249
- Sponsor's protocol ID
- RUTF18
- Status last verified
- Aug 2019
- First submitted
- 29 Jul 2019
- Last updated
- 5 Aug 2019
- 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 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Feeding Protocols and Existing Protocol for the Treatment of Acute Malnutrition (A Cluster Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04045249
- Acronym / sponsor ID
- RUTF18
- Conditions
- Malnutrition, Child
- Keywords
- Malnutrition, RUTF, Children, Home base food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, PunjabOther government
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 5 Aug 2019 (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.
Though malnutrition is prevalent worldwide but its situation is alarming in low- and middle-income countries. Pakistan has also been facing an alarming situation of prevailing severe malnutrition. Malnutrition in its any form costs a huge intolerable burden not only on national health care system, but also on social and economic fabric of the nation. The current management of severe malnutrition is based on World Health Organization (WHO) guidelines and protocols which has been evolved from expert opinions and observational studies. The principles of these protocols have emerged from emergency settings and converting these protocols for developing countries where severe malnutrition, a routine burden is a critical challenge. In the absence of standard protocols for the treatment of uncomplicated severe malnutrition in non-emergency settings it is important to test and optimize different approaches to treat severely acute malnutrition (SAM). It is hypothesized that by optimizing, adapting and implementing time oriented and resource intensive approaches, a huge burden of high cost of RUTF may be reduced. While RUTF may be utilized to treat SAM children in emergency settings, it is not a substitute of local household foods. Therefore, a pilot study has been conducted to compare the various treatment protocols for malnourished children. We specifically hypothesized that a reduced dose of RUTF for reduced duration, combined with age-appropriate food intake from locally available resources can treat uncomplicated SAM children cost effectively as compared to standard national Community Management of Acute Malnutrition (CMAM) protocol currently implemented in Punjab, Pakistan.
Detailed description
Malnutrition signifies to inadequacies, immoderations or imbalances in an individual's consumption of nutrients or energy. The word malnutrition covers both under and over-nutrition. Undernutrition manifest in two different ways acute and chronic malnutrition. The acute malnutrition includes wasting while chronic malnutrition includes stunting. The situation of malnutrition has been perplexed in Pakistan in recent years and according to National Nutrition Survey (2018) rates of wasting are alarmingly high. Also, Pakistan ranks at 2nd position for infant and child mortality. The standard treatment of uncomplicated SAM in Pakistan often utilizes prolonged use of therapeutic food (RUTF), and after discharge results in high rates of relapse(official data from department of Health doesn't support this statement, according to them there is low rate of relapse). The present pilot study was conducted with the objective to find cost effective treatment protocols for treatment of uncomplicated SAM children. The study was conducted at The Children's Hospital and Institute of Child Health, Lahore in Out Patient Therapeutic Program (OTP) of Preventive Pediatrics Department. The children diagnosed with SAM aged 6-59 months without any specific gender preference were recruited. Weight, height and MUAC were measured at the time of enrolment in the study and Weight for Height (WHZ), Weight for Age (WAZ), Height for Age (HAZ) standard deviation (SD) Z scores and weight velocity was calculated for baseline. For current pilot study SAM children were grouped into 3 clusters. First, 30 children were grouped in 1st cluster, next 30 in 2nd cluster and further next 30 in 3rd cluster. Children in 1st cluster were treated as per standard CMAM protocols. Children in this cluster were provided RUTF as per admission weight of child until they attain 11.5cm MUAC or >-3SD WHZ. The children in the 2nd group (1st intervention group) were initially provided RUTF until they attain MUAC 11cm. After this, children were provided 50% of their required daily calories intake by RUTF and 50% of the calories were provided by the home-based food. The children in the 3rd group (2nd intervention group) were initially provided RUTF until they attain MUAC 11 cm. After this, children were provided their 100% caloric requirement from home-based food along with micronutrients sachets (MMS). The discharge criteria for control group was according to the existing CMAM guidelines that is MUAC > 11.5 cm. The discharge criteria for 2nd \& 3rd group was MUAC > 12.5 cm and WHZ > -2SD score. Follow-up home visits of all children were done according to a predefined protocol. During follow-up the control and intervention groups underwent weekly anthropometric measurements. Follow up of the study participants of each group was continued for one month. Growth rate, recovery rate, mortality rate, relapse frequency and duration of recovery were calculated for each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Study involved 3 arms; 1st arm was treated as per standard protocol. 2nd arm was provided half calories from RUTF and half from home based food, 3rd arm was provided home based food along with MMS
| Arm | Type | Receives |
|---|---|---|
| 1st Group | No intervention | –Children were treated as per standard CMAM protocols; provided RUTF until MUAC reaches 11.5 cm |
| 2nd Group (1st Intervention group) | Experimental | Dietary Supplement: Home based foodChildren were initially provided RUTF until MUAC reach 11 cm then 50 % calories were provided from RUTF and 50% calories from home based food |
| 3rd Group (2nd Intervention) | Experimental | Dietary Supplement: Home based foodChildren were initially provided RUTF until MUAC reach 11 cm then 100 % calories provided from home based food |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 6-59 months with MUAC <11.5cm and Weight for Height Z score < -3SD
- Having good appetite, alert and clinically well
Key exclusion criteria (14 listed)
- WHZ score - 4 SD
- MUAC < 8 cm
- Secondary malnutrition diagnosed by a gastroenterologist and dietitian
- Family History
- Birth Anomolies
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 |
|---|---|---|
| Home based foodHome based food is compare able to RUTF | Dietary supplement | 2nd Group (1st Intervention group), 3rd Group (2nd Intervention) |
Primary outcome
Growth velocity
Time frame: 3 months
Weight in Kg
Growth velocity
Time frame: 3 months
Height in cm
Growth velocity
Time frame: 3 months
Mid Upper Arm Circumference (MUAC) in cm
Duration of recovery from SAM
Time frame: 3 months
Time required each child to reach MUAC > 11.5
Rate of relapse
Time frame: 3 months
Number of children relapsed during the trial
Rate of mortality
Time frame: 3 months
Number of children dying during trial
3 secondary outcomes
Rate of recovery from Moderate Acute Malnutrition in 1st group
Time frame: 3 months
Number of children having diarrhoea and acute respiratory infection during trial
Time frame: 3 months
Number of children not coming for follow up visits due to any reason
Time frame: 3 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 5 Aug 2019.
- 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.
Zahra Khan, PhD principal investigator
IRMNCH & Nutrition Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based food in people with Malnutrition, Child, run by Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab at 1 site in Pakistan.
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 14 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 5 Aug 2019. 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 Pakistan. 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?
Growth velocity (time frame: 3 months). 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?
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 5 Aug 2019.