StuntingNCT03299218
Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan
A study testing SNF (Wawamum), Social and behaviour change communication (SBCC) and Cash in people with Stunting, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Read more about this study
- Who is it for?
- Ages 6 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Stunting
- What is being tested?
- SNF (Wawamum), Social and behaviour change communication (SBCC) and Cash
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,179 participants
- Where
- 1 sitePakistan
- Study dates
- 26 May 2017to 31 Jul 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 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- BISP beneficiary for intervention arms and poverty score between 16.18 - 20.00 according to the BISP approach for control group;
- Living in the catchment area of LHW;
- Have at least one child of 6-7 months old at the time of inclusion, and;
- Willing and able to provide written informed consent for the study.
Who cannot join
- Non BISP households
- Planning to migrate form the study area in next 18 months
- Unable to provide written informed consent
- Children with severe malnutrition and/or chronic illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Programme Comprised of SNF, Cash-based Transfers and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Punjab, Pakistan
Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.
Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are quite evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.
Given the alarming situation of child malnutrition in district Rahim Yar Khan, the World Food Program (WFP) Pakistan is proposing an intervention program comprised of cash-based transfers, specialized nutritious foods and behaviours change communication to prevent stunting in district Rahim Yar Khan, province Punjab. The interventions will be delivered through the existing health system and Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. Therefore, the Department of Paediatrics and Child Health, Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan to assess the effectiveness of the WFP interventions on process and outcome indicators.
Read the detailed description
Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.
The second Lancet Series on Maternal and Child Under-nutrition (2013) and the Scaling-Up Nutrition (SUN) Initiative give some recommendations on selected effective approaches for the management and prevention of under-nutrition, such as breastfeeding counselling or micronutrient supplementation, but evidence gaps still remain, particularly concerning indirect interventions. The World Health Organization highlighted in 2010 the need to consider prevention strategies when implementing programs aiming at reducing stunting rates. There is also evidence showing that preventive programs, such as supplementation, can be more effective to reduce childhood under-nutrition than nutrition rehabilitation. Reviews on cash transfer experiences show that this type of intervention has the potential to prevent undernutrition. However, most of the cash transfer programs implemented and scientifically evaluated do not have a clear nutritional objective, which leads to inconclusive evidence regarding their nutritional benefits.
Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are especially evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.
Given the alarming situation of child malnutrition in Rahim Yar Khan district, the World Food Programme (WFP) Pakistan is proposing an intervention programme comprised of cash-based transfers, specialized nutritious foods and behavior change communication to prevent stunting in Rahim Yar Khan district, Punjab province. The interventions will be delivered through the existing health system and the social protection programme, Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. The study will be conducted by the Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan. This document will describe the methods and strategies that AKU will employ to assess the effectiveness of the interventions on process and outcome indicators.
- Conditions
- Stunting
- Being tested
- SNF (Wawamum), Social and behaviour change communication (SBCC), Cash
- Keywords
- Specialized Nutritious Food (SNF), Social and Behaviour change communication (SBCC), Cash-based transfers
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNF (Wawamum)Dietary supplement
A monthly ration of 30 sachets of SNF (one 50 gram sachet of Wawamum per child per day) will be provided by LHWs. Each recruited child will receive SNF on a monthly basis for the duration of 18 months during his/her age of 6-24 months.
Social and behaviour change communication (SBCC)Behavioural
SBCC messages will be delivered by LHWs in their monthly routine household visits. Male and female group sessions will be arranged on quarterly basis with the help of health committees.
CashOther
Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receiving current Government of Punjab health services |
| Cash-based transfers | Experimental | Cash-based transfers only by BISP Receives: Other: Cash |
| Cash with SBCC | Experimental | Cash-based transfers and Social \& behaviour change communication (SBCC) Receives: Behavioral: Social and behaviour change communication (SBCC); Other: Cash |
| Cash with SNF (Wawamum) | Experimental | Cash-based transfers and SNF (Wawamum) Receives: Dietary Supplement: SNF (Wawamum); Other: Cash |
| Cash,SNF (Wawamum) & SBCC | Experimental | Cash-based transfers, SNF (Wawamum) and SBCC Receives: Dietary Supplement: SNF (Wawamum); Behavioral: Social and behaviour change communication (SBCC); Other: Cash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in stunting
10% reduction in stunting in children
Measured: 18 months
SBCC package on the basis of formative research
SBCC package will be developed on the basis of formative research
Measured: 3 months
Cost-effectiveness of intervention packages for prevention of stunting in children
Cost effectiveness analysis will run through the full three years of the program cost
Measured: 18 months
Secondary outcomes (7)
Weight gain in kilograms
Child weight in kilograms will be measured on monthly basis
Measured: 18 months
Length gain in centimeters
Child length in centimeters will be measured on monthly basis
Measured: 18 months
Impact of the intervention on micronutrient deficiencies
Impact of the intervention on micronutrient deficiencies will be measured at 24 months by biochemical analysis
Measured: At 24 months of age
Improvement in IYCF practices
Improvement in IYCF practices will be measured from monthly follow-up data
Measured: 18 months
Improved nutrition, hygiene and health related knowledge and practices
Improved nutrition, hygiene and health related knowledge and practices will be measured from endline KAP data
Measured: 18 months
Proportion of households with moderate or severe hunger (food insecurity)
Food insecurity will be measured from baseline and endline data
Measured: 18 months
Uptake of health services and interventions
Uptake of health services and interventions will be measured from baseline and endline data
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start26 May 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 1. Control Group 2. Cash-based transfers only by BISP 3. Cash-based transfers and Social \& behaviour change communication (SBCC) 4. Cash-based transfer and SNF 5. Cash-based transfers, SNF and SBCC
- Masking
- None (open label)
- Enrolment
- 2,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Benazir Income Support Programme (BISP), Punjab Health Care Commission, World Food Programme (WFP)
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
- Investigators
- Sajid B Soofi, FCPS, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299218
- Sponsor's protocol ID
- CBT Study Rahim Yar Khan
- Status last verified
- Mar 2020
- First submitted
- 12 Aug 2017
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Onah MN, Khan GN, Kureishy S, Bourdaire J, de Pee S, Garzon C, Ihtesham Y, Akbar N, Soofi SB. The cost-effectiveness of a cash-based transfer, specialised nutritious food, and social and behaviour change communication intervention package to prevent undernutrition among children 6-23 months in Pakistan: A cluster randomised controlled trial. J Glob Health. 2024 Nov 22;14:04186. doi: 10.7189/jogh.14.04186.
PubMed 39575728Soofi SB, Ariff S, Khan GN, Habib A, Kureishy S, Ihtesham Y, Hussain M, Rizvi A, Sajid M, Akbar N, Garzon C, de Pee S, Bhutta ZA. Effectiveness of unconditional cash transfers combined with lipid-based nutrient supplement and/or behavior change communication to prevent stunting among children in Pakistan: a cluster randomized controlled trial. Am J Clin Nutr. 2022 Feb 9;115(2):492-502. doi: 10.1093/ajcn/nqab341.
PubMed 34612491Khan GN, Kureishy S, Ariff S, Habib MA, Usmani AA, Mubarik A, Hussain M, Akbar N, Rodriguez de Castro P, Garzon AC, de Pee S, Soofi SB. Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 24;9(8):e19001. doi: 10.2196/19001.
PubMed 32831183
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Programme Comprised of SNF, Cash-based Transfers and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Punjab, Pakistan
- ClinicalTrials.gov ID
- NCT03299218
- Acronym / sponsor ID
- CBT Study Rahim Yar Khan
- Conditions
- Stunting
- Keywords
- Specialized Nutritious Food (SNF), Social and Behaviour change communication (SBCC), Cash-based transfers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,179 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Benazir Income Support Programme (BISP), Punjab Health Care Commission, World Food Programme (WFP)
- Study start
- 26 May 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 3 Oct 2017 (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.
Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.
Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are quite evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.
Given the alarming situation of child malnutrition in district Rahim Yar Khan, the World Food Program (WFP) Pakistan is proposing an intervention program comprised of cash-based transfers, specialized nutritious foods and behaviours change communication to prevent stunting in district Rahim Yar Khan, province Punjab. The interventions will be delivered through the existing health system and Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. Therefore, the Department of Paediatrics and Child Health, Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan to assess the effectiveness of the WFP interventions on process and outcome indicators.
Detailed description
Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations.
The second Lancet Series on Maternal and Child Under-nutrition (2013) and the Scaling-Up Nutrition (SUN) Initiative give some recommendations on selected effective approaches for the management and prevention of under-nutrition, such as breastfeeding counselling or micronutrient supplementation, but evidence gaps still remain, particularly concerning indirect interventions. The World Health Organization highlighted in 2010 the need to consider prevention strategies when implementing programs aiming at reducing stunting rates. There is also evidence showing that preventive programs, such as supplementation, can be more effective to reduce childhood under-nutrition than nutrition rehabilitation. Reviews on cash transfer experiences show that this type of intervention has the potential to prevent undernutrition. However, most of the cash transfer programs implemented and scientifically evaluated do not have a clear nutritional objective, which leads to inconclusive evidence regarding their nutritional benefits.
Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are especially evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014.
Given the alarming situation of child malnutrition in Rahim Yar Khan district, the World Food Programme (WFP) Pakistan is proposing an intervention programme comprised of cash-based transfers, specialized nutritious foods and behavior change communication to prevent stunting in Rahim Yar Khan district, Punjab province. The interventions will be delivered through the existing health system and the social protection programme, Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. The study will be conducted by the Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan. This document will describe the methods and strategies that AKU will employ to assess the effectiveness of the interventions on process and outcome indicators.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 1. Control Group 2. Cash-based transfers only by BISP 3. Cash-based transfers and Social \& behaviour change communication (SBCC) 4. Cash-based transfer and SNF 5. Cash-based transfers, SNF and SBCC
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receiving current Government of Punjab health services |
| Cash-based transfers | Experimental | Other: CashCash-based transfers only by BISP |
| Cash with SBCC | Experimental | Behavioral: Social and behaviour change communication (SBCC), Other: CashCash-based transfers and Social \& behaviour change communication (SBCC) |
| Cash with SNF (Wawamum) | Experimental | Dietary Supplement: SNF (Wawamum), Other: CashCash-based transfers and SNF (Wawamum) |
| Cash,SNF (Wawamum) & SBCC | Experimental | Dietary Supplement: SNF (Wawamum), Behavioral: Social and behaviour change communication (SBCC), Other: CashCash-based transfers, SNF (Wawamum) and SBCC |
Who may qualify
- Ages
- 6 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- BISP beneficiary for intervention arms and poverty score between 16.18 - 20.00 according to the BISP approach for control group;
- Living in the catchment area of LHW;
- Have at least one child of 6-7 months old at the time of inclusion, and;
- Willing and able to provide written informed consent for the study.
Key exclusion criteria (4 listed)
- Non BISP households
- Planning to migrate form the study area in next 18 months
- Unable to provide written informed consent
- Children with severe malnutrition and/or chronic illness
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 |
|---|---|---|
| SNF (Wawamum)A monthly ration of 30 sachets of SNF (one 50 gram sachet of Wawamum per child per day) will be provided by LHWs. Each recruited child will receive SNF on a monthly basis for the duration of 18 months during his/her age of 6-24 months. | Dietary supplement | Cash with SNF (Wawamum), Cash,SNF (Wawamum) & SBCC |
| Social and behaviour change communication (SBCC)SBCC messages will be delivered by LHWs in their monthly routine household visits. Male and female group sessions will be arranged on quarterly basis with the help of health committees. | Behavioural | Cash with SBCC, Cash,SNF (Wawamum) & SBCC |
| CashCash totaling 1600 rupees per month will be transferred by BISP throughout the study period. | Other | Cash with SBCC, Cash with SNF (Wawamum), Cash,SNF (Wawamum) & SBCC, Cash-based transfers |
Primary outcome
Reduction in stunting
Time frame: 18 months
10% reduction in stunting in children
SBCC package on the basis of formative research
Time frame: 3 months
SBCC package will be developed on the basis of formative research
Cost-effectiveness of intervention packages for prevention of stunting in children
Time frame: 18 months
Cost effectiveness analysis will run through the full three years of the program cost
7 secondary outcomes
Weight gain in kilograms
Time frame: 18 months
Length gain in centimeters
Time frame: 18 months
Impact of the intervention on micronutrient deficiencies
Time frame: At 24 months of age
Improvement in IYCF practices
Time frame: 18 months
Improved nutrition, hygiene and health related knowledge and practices
Time frame: 18 months
Proportion of households with moderate or severe hunger (food insecurity)
Time frame: 18 months
Uptake of health services and interventions
Time frame: 18 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 19 Mar 2020.
- Derived from this study: PubMed 39575728Onah MN, Khan GN, Kureishy S, Bourdaire J, de Pee S, Garzon C, Ihtesham Y, Akbar N, Soofi SB. The cost-effectiveness of a cash-based transfer, specialised nutritious food, and social and behaviour change communication intervention package to prevent undernutrition among children 6-23 months in Pakistan: A cluster randomised controlled trial. J Glob Health. 2024 Nov 22;14:04186. doi: 10.7189/jogh.14.04186.
- Derived from this study: PubMed 34612491Soofi SB, Ariff S, Khan GN, Habib A, Kureishy S, Ihtesham Y, Hussain M, Rizvi A, Sajid M, Akbar N, Garzon C, de Pee S, Bhutta ZA. Effectiveness of unconditional cash transfers combined with lipid-based nutrient supplement and/or behavior change communication to prevent stunting among children in Pakistan: a cluster randomized controlled trial. Am J Clin Nutr. 2022 Feb 9;115(2):492-502. doi: 10.1093/ajcn/nqab341.
- Derived from this study: PubMed 32831183Khan GN, Kureishy S, Ariff S, Habib MA, Usmani AA, Mubarik A, Hussain M, Akbar N, Rodriguez de Castro P, Garzon AC, de Pee S, Soofi SB. Specialized Nutritious Food Combined With Cash Transfers and Social and Behavior Change Communication to Prevent Stunting Among Children Aged 6 to 23 Months in Pakistan: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2020 Aug 24;9(8):e19001. doi: 10.2196/19001.
- 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.
Sajid B Soofi, FCPS, MBBS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNF (Wawamum), Social and behaviour change communication (SBCC) and Cash in people with Stunting, run by Aga Khan University 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 4 inclusion and 4 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 19 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 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?
Reduction in stunting (time frame: 18 months). The study lists 3 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 NCT03299218, 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 19 Mar 2020.