Child Nutrition DisordersSAMMANNCT02671786
Community Based Management of Severe Malnutrition in Tribal Area of Melghat- Cluster Randomized Control Field Trial
A study testing MAHAN RUTF & MAHAN Vit-Min mix in people with Child Nutrition Disorders and Malnutrition, run by MAHAN Trust at 1 site in India.
Trial summary
Provision of community based health care to severely malnourished children (Age group: 6 months through 5 years) in 16 tribal villages by trained semi-literate village health workers. 1. Treatment of severely malnourished children. 2. Growth monitoring of all children below the age of 5 years. 3. Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Child Nutrition Disorders, Malnutrition
- What is being tested?
- MAHAN RUTF & MAHAN Vit-Min mix
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 1 siteIndia
- Study dates
- May 2011to Sep 2015
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children suffering from severe malnutrition as per weight for height criteria (WHO), weight for age criteria (WHO), MUAC (WHO), IAP grade III \& IV. Defacto method.
Who cannot join
- Children who have failed in appetite test and cannot tolerate oral F75 food. Also,
- Parents, guardian refuse to give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Based Management of Severe Malnutrition in Under 5 Children in Tribal Area of Melghat, Maharashtra- Cluster Randomized Control Field Trial
Provision of community based health care to severely malnourished children (Age group: 6 months through 5 years) in 16 tribal villages by trained semi-literate village health workers.
- Treatment of severely malnourished children.
- Growth monitoring of all children below the age of 5 years.
- Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.
- Management of resistant or relapsed severely malnourished cases by pediatrician.
- Intensive behavior change communication of parents of children below the age of 5 years for proper nutrition.
Read the detailed description
- Title of project: SAMMAN- Community based management of severe malnutrition in under 5 children in tribal area of Melghat region
- Name of Institution: MAHAN Trust, Address: Mahatma Gandhi Tribal Hospital, Karmagram . Utavali, tehsil- Dharni, Melghat (Amaravati)
- Objectives -
- To reduce the child mortality (in the age of group of 6 months to 5 years) due to severe malnutrition in tribal area of Melghat by 35% in usual residents population of 15000 (from 16 villages) over a period of 3 years.
- To reduce the prevalence of severe malnutrition (in the age of group of 6 months to 5 years) by at least 35% in usual residents population of 15000 from 16 villages in tribal area of Melghat over a period of 3 years.
- To achieve Case fatality rate of 2 % of treated severely malnourished children.
- Need and rational of the project : Melghat is a hilly difficult to approach tribal forest terrain in Amaravati district of Maharashtra, India . Population is 2,80,000 \& 75% of them are tribal. Most of the tribal (>90 %) are farmers or laborers, living below poverty line(>75%) \& very hard life in huts without electricity (>90%) \& illiterate (>50%). Medical facilities are worst in Melghat as compared to rest of Maharashtra. A detailed study conducted by MAHAN showed that more than 20% of tribal children are severely malnourished and the under 5 children mortality rate is more than 100 per 1000 live births due to lack of proper nutrition, medical facilities, superstitions \& reluctance for hospitalization of severely malnourished children. There is an immediate need to fight severe malnutrition in children between the ages of 6 months to 5 years. This project is being implemented as a pilot project in 16 villages of Melghat which has potential for replication in all tribal and rural part of India.
- Methodology Study design: The study is a cluster randomized parallel group controlled field trial Study area: 35 tribal villages selected from 5 clusters of Melghat by lottery method divided into intervention and control area. Sample size - 1500 severely malnourished children from intervention and control area each.
- Intervention:
Provision of community based health care to severely malnourished children (Age group: 6 months through 5 years) in 16 tribal villages by trained semi-literate village health workers.
- Treatment of severely malnourished children .
- Growth monitoring of all children below the age of 5 years.
- Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.
- Management of resistant or relapsed severely malnourished cases by pediatrician.
- Intensive behavior change communication of parents of children below the age of 5 years for proper nutrition.
- Duration: 5 years (May 2011 to September 2015)
- Monitoring indicators for the outcome objectives:
Primary outcomes
- Prevalence of severe malnutrition (Severe Acute Malnutrition; Severe Underweight and Indian Academy of Pediatrician (IAP) Grade III, IV)
- No. of child deaths due to severe malnutrition
- Case fatality rate of treated severely malnourished children The secondary outcomes
- Child mortality rate between 6 to 60 months age group The secondary outcomes
- Child mortality rate between 6 to 60 months age group
- Scope \& end result expected of project
- Lives of 1500 severely malnourished children from Melghat will be saved.
- This model of community based management of severe malnourished children using RUTF prepared by local tribal females from local produce will have better socio-cultural acceptance by parents, and will be palatable for children, hence will be more effective.
- It will also be useful in long term for preventing recurrences and roll back cases as parents awareness will be improved with behavior change communication.
- Based on this study, national and international policies related to community based management of severely malnourished children may be framed.
- It will be a step towards fulfillment of fundamental rights of children guaranteed by constitution of India.
- Conditions
- Child Nutrition Disorders, Malnutrition
- Being tested
- MAHAN RUTF & MAHAN Vit-Min mix
- Keywords
- Severe Acute Malnutrition, Severe Underweight, IAP Grade III-IV, Severe Stunting, Village Health Workers, MAHAN RUTF & MAHAN Vit-Mim mix
- Medical subject headings
- Child Nutrition Disorders, Malnutrition, Severe Acute Malnutrition, Thinness, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAHAN RUTF & MAHAN Vit-Min mixOther
MAHAN RUTF dishes are locally prepared by local tribal women and each packet of RUTF provides 500-550 calories \& 15-17 gms of proteins.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Intervention area: Provision of community based health care to severely malnourished children 6 months age in 16 tribal villages by trained semi-literate village health workers.
1. Treatment of severely malnourished children through MAHAN RUTF \& MAHAN Vit-Min mix
2. Growth monitoring of all children below the age of 5 years
3. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.
4. Management of resistant or relapsed severely malnourished cases by pediatrician.
5. Intensive behavior change communication of parents of children below the age of 5 years for proper nutrition.
Dose: 46 gms of proteins/kg/day \& 100170 calories/kg/day with gradual escalation with micro nutrient supplementation Route: Oral Frequency: 4 times a day Duration: 12 weeks Receives: Other: MAHAN RUTF & MAHAN Vit-Min mix |
| Control Arm | No intervention | Control area: In control area, the V.H.W. and supervisor records weight of all under 5 children. They also collect data related to birth, deaths and verbal autopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate of SAM (Severe Acute Malnutrition), SUW (Severe Underweight) and IAP Grade III,IV
Measured: At the end of therapeutic cycle of 3 months
Case fatality rate of treated severely malnourished children
Measured: At the end of therapeutic cycle of 3 months
Prevalence of severe malnutrition (SAM, SUW, IAP Grade III,IV)
Measured: Over the period of 3 years
Secondary outcomes (1)
Child mortality rate ( 6 months to 60 months age group)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startMay 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Child Nutrition DisordersStudies 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
- Masking
- None (open label)
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- MAHAN Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vibhawari Dani, MBBS; MD, Principal investigator, Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671786
- Sponsor's protocol ID
- MT-2 SAMMAN
- Acronym
- SAMMAN
- Status last verified
- Jan 2016
- First submitted
- 10 Jan 2016
- Last updated
- 2 Feb 2016
- Results posted
- No
Publications
Management of Severe Under Nutrition, A Manual for Physicians and Other Health Workers. Geneva: WHO; 1999.
Pelletier DL, Frongillo EA Jr, Schroeder DG, Habicht JP. The effects of malnutrition on child mortality in developing countries. Bull World Health Organ. 1995;73(4):443-8.
PubMed 7554015Meshram II, Arlappa N, Balakrishna N, Laxmaiah A, Mallikarjun Rao K, Gal Reddy Ch, Ravindranath M, Sharad Kumar S, Brahmam GN. Prevalence and determinants of undernutrition and its trends among pre-school tribal children of Maharashtra State, India. J Trop Pediatr. 2012 Apr;58(2):125-32. doi: 10.1093/tropej/fmr035. Epub 2011 May 4.
PubMed 21543411Dani V, Satav A, Pendharkar J, Ughade S, Jain D, Adhav A et al. Prevalence of under nutrition in under-five tribal children of Melghat: A community based cross sectional study in Central India, Clinical Epidemiology and Global Health 2014 Sept, I-8
Amsalu S, Tigabu Z. Risk factors for severe acute malnutrition in children under the age of five: A case-control study. Ethiop J Health Dev. 2008; 22(1): 21-5.
Ashworth A. Efficacy and effectiveness of community-based treatment of severe malnutrition. Food Nutr Bull. 2006 Sep;27(3 Suppl):S24-48. doi: 10.1177/15648265060273S303.
PubMed 17076212WHO/UNICEF/WFP/SCN Joint statement. Community-based management of severe malnutrition. Geneva, New York, Rome, 2007
Manary MJ, Ndkeha MJ, Ashorn P, Maleta K, Briend A. Home based therapy for severe malnutrition with ready-to-use food. Arch Dis Child. 2004 Jun;89(6):557-61. doi: 10.1136/adc.2003.034306.
PubMed 15155403Schoonees A, Lombard M, Musekiwa A, Nel E, Volmink J. Ready-to-use therapeutic food for home-based treatment of severe acute malnutrition in children from six months to five years of age. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD009000. doi: 10.1002/14651858.CD009000.pub2.
PubMed 23744450Bergeron G, Castleman T. Program responses to acute and chronic malnutrition: divergences and convergences. Adv Nutr. 2012 Mar 1;3(2):242-9. doi: 10.3945/an.111.001263.
PubMed 22516735Ashworth A., Community-Based Rehabilitation of Severely Malnourished Children: a Review of Successful Programmes. London School of Hygiene and Tropical Medicine. Report. 2001
Dasgupta R, Sinha D, Yumnam V. Programmatic response to malnutrition in India, room for more than one elephant. Indian Pediatr. 2014 Nov;51(11):863-8. doi: 10.1007/s13312-014-0518-5.
PubMed 25432212Dasgupta R, Ahuja S, Yumnam V. Can nutrition rehabilitation centers address severe malnutrition in India? Indian Pediatr. 2014 Feb;51(2):95-9. doi: 10.1007/s13312-014-0341-z.
PubMed 24632690Rogers BL , Rajabiun S, Levinson J, Tucker K. Reducing Chronic Malnutrition in Peru: A Proposed National Strategy
READY-TO-USE THERAPEUTIC FOOD FOR CHILDREN WITH SEVERE ACUTE MALNUTRITION- A position paper by UNICEF
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Management of Severe Malnutrition in Under 5 Children in Tribal Area of Melghat, Maharashtra- Cluster Randomized Control Field Trial
- ClinicalTrials.gov ID
- NCT02671786
- Acronym / sponsor ID
- SAMMAN / MT-2 SAMMAN
- Conditions
- Child Nutrition Disorders, Malnutrition
- Keywords
- Severe Acute Malnutrition, Severe Underweight, IAP Grade III-IV, Severe Stunting, Village Health Workers, MAHAN RUTF & MAHAN Vit-Mim mix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- MAHAN TrustUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 2 Feb 2016 (estimated)
- 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.
Provision of community based health care to severely malnourished children (Age group: 6 months through 5 years) in 16 tribal villages by trained semi-literate village health workers.
- Treatment of severely malnourished children.
- Growth monitoring of all children below the age of 5 years.
- Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.
- Management of resistant or relapsed severely malnourished cases by pediatrician.
- Intensive behavior change communication of parents of children below the age of 5 years for proper nutrition.
Detailed description
- Title of project: SAMMAN- Community based management of severe malnutrition in under 5 children in tribal area of Melghat region
- Name of Institution: MAHAN Trust, Address: Mahatma Gandhi Tribal Hospital, Karmagram . Utavali, tehsil- Dharni, Melghat (Amaravati)
- Objectives -
- To reduce the child mortality (in the age of group of 6 months to 5 years) due to severe malnutrition in tribal area of Melghat by 35% in usual residents population of 15000 (from 16 villages) over a period of 3 years.
- To reduce the prevalence of severe malnutrition (in the age of group of 6 months to 5 years) by at least 35% in usual residents population of 15000 from 16 villages in tribal area of Melghat over a period of 3 years.
- To achieve Case fatality rate of 2 % of treated severely malnourished children.
- Need and rational of the project : Melghat is a hilly difficult to approach tribal forest terrain in Amaravati district of Maharashtra, India . Population is 2,80,000 \& 75% of them are tribal. Most of the tribal (>90 %) are farmers or laborers, living below poverty line(>75%) \& very hard life in huts without electricity (>90%) \& illiterate (>50%). Medical facilities are worst in Melghat as compared to rest of Maharashtra. A detailed study conducted by MAHAN showed that more than 20% of tribal children are severely malnourished and the under 5 children mortality rate is more than 100 per 1000 live births due to lack of proper nutrition, medical facilities, superstitions \& reluctance for hospitalization of severely malnourished children. There is an immediate need to fight severe malnutrition in children between the ages of 6 months to 5 years. This project is being implemented as a pilot project in 16 villages of Melghat which has potential for replication in all tribal and rural part of India.
- Methodology Study design: The study is a cluster randomized parallel group controlled field trial Study area: 35 tribal villages selected from 5 clusters of Melghat by lottery method divided into intervention and control area. Sample size - 1500 severely malnourished children from intervention and control area each.
- Intervention:
Provision of community based health care to severely malnourished children (Age group: 6 months through 5 years) in 16 tribal villages by trained semi-literate village health workers.
- Treatment of severely malnourished children .
- Growth monitoring of all children below the age of 5 years.
- Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc.
- Management of resistant or relapsed severely malnourished cases by pediatrician.
- Intensive behavior change communication of parents of children below the age of 5 years for proper nutrition.
- Duration: 5 years (May 2011 to September 2015)
- Monitoring indicators for the outcome objectives:
Primary outcomes
- Prevalence of severe malnutrition (Severe Acute Malnutrition; Severe Underweight and Indian Academy of Pediatrician (IAP) Grade III, IV)
- No. of child deaths due to severe malnutrition
- Case fatality rate of treated severely malnourished children The secondary outcomes
- Child mortality rate between 6 to 60 months age group The secondary outcomes
- Child mortality rate between 6 to 60 months age group
- Scope \& end result expected of project
- Lives of 1500 severely malnourished children from Melghat will be saved.
- This model of community based management of severe malnourished children using RUTF prepared by local tribal females from local produce will have better socio-cultural acceptance by parents, and will be palatable for children, hence will be more effective.
- It will also be useful in long term for preventing recurrences and roll back cases as parents awareness will be improved with behavior change communication.
- Based on this study, national and international policies related to community based management of severely malnourished children may be framed.
- It will be a step towards fulfillment of fundamental rights of children guaranteed by constitution of India.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: MAHAN RUTF & MAHAN Vit-Min mixIntervention area: Provision of community based health care to severely malnourished children 6 months age in 16 tribal villages by trained semi-literate village health workers. 1. Treatment of severely malnourished children through MAHAN RUTF \& MAHAN Vit-Min mix 2. Growth monitoring of all children below the age of 5 years 3. Treatment of associated diseases like Diarrhea, Pneumonia, Malaria, etc. 4. Management of resistant or relapsed severely malnourished cases by pediatrician. 5. Intensive behavior change communication of parents of children below the age of 5 years for proper nutrition. Dose: 46 gms of proteins/kg/day \& 100170 calories/kg/day with gradual escalation with micro nutrient supplementation Route: Oral Frequency: 4 times a day Duration: 12 weeks |
| Control Arm | No intervention | –Control area: In control area, the V.H.W. and supervisor records weight of all under 5 children. They also collect data related to birth, deaths and verbal autopsy. |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children suffering from severe malnutrition as per weight for height criteria (WHO), weight for age criteria (WHO), MUAC (WHO), IAP grade III \& IV. Defacto method.
Key exclusion criteria (2 listed)
- Children who have failed in appetite test and cannot tolerate oral F75 food. Also,
- Parents, guardian refuse to give consent.
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 |
|---|---|---|
| MAHAN RUTF & MAHAN Vit-Min mixMAHAN RUTF dishes are locally prepared by local tribal women and each packet of RUTF provides 500-550 calories \& 15-17 gms of proteins. | Other | Intervention Arm |
Primary outcome
Recovery rate of SAM (Severe Acute Malnutrition), SUW (Severe Underweight) and IAP Grade III,IV
Time frame: At the end of therapeutic cycle of 3 months
Case fatality rate of treated severely malnourished children
Time frame: At the end of therapeutic cycle of 3 months
Prevalence of severe malnutrition (SAM, SUW, IAP Grade III,IV)
Time frame: Over the period of 3 years
1 secondary outcome
Child mortality rate ( 6 months to 60 months age group)
Time frame: 3 years
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 2 Feb 2016.
- BackgroundManagement of Severe Under Nutrition, A Manual for Physicians and Other Health Workers. Geneva: WHO; 1999.
- Background: PubMed 7554015Pelletier DL, Frongillo EA Jr, Schroeder DG, Habicht JP. The effects of malnutrition on child mortality in developing countries. Bull World Health Organ. 1995;73(4):443-8.
- Background: PubMed 21543411Meshram II, Arlappa N, Balakrishna N, Laxmaiah A, Mallikarjun Rao K, Gal Reddy Ch, Ravindranath M, Sharad Kumar S, Brahmam GN. Prevalence and determinants of undernutrition and its trends among pre-school tribal children of Maharashtra State, India. J Trop Pediatr. 2012 Apr;58(2):125-32. doi: 10.1093/tropej/fmr035. Epub 2011 May 4.
- BackgroundDani V, Satav A, Pendharkar J, Ughade S, Jain D, Adhav A et al. Prevalence of under nutrition in under-five tribal children of Melghat: A community based cross sectional study in Central India, Clinical Epidemiology and Global Health 2014 Sept, I-8
- BackgroundAmsalu S, Tigabu Z. Risk factors for severe acute malnutrition in children under the age of five: A case-control study. Ethiop J Health Dev. 2008; 22(1): 21-5.
- Background: PubMed 17076212Ashworth A. Efficacy and effectiveness of community-based treatment of severe malnutrition. Food Nutr Bull. 2006 Sep;27(3 Suppl):S24-48. doi: 10.1177/15648265060273S303.
- BackgroundWHO/UNICEF/WFP/SCN Joint statement. Community-based management of severe malnutrition. Geneva, New York, Rome, 2007
- Background: PubMed 15155403Manary MJ, Ndkeha MJ, Ashorn P, Maleta K, Briend A. Home based therapy for severe malnutrition with ready-to-use food. Arch Dis Child. 2004 Jun;89(6):557-61. doi: 10.1136/adc.2003.034306.
- Background: PubMed 23744450Schoonees A, Lombard M, Musekiwa A, Nel E, Volmink J. Ready-to-use therapeutic food for home-based treatment of severe acute malnutrition in children from six months to five years of age. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD009000. doi: 10.1002/14651858.CD009000.pub2.
- Background: PubMed 22516735Bergeron G, Castleman T. Program responses to acute and chronic malnutrition: divergences and convergences. Adv Nutr. 2012 Mar 1;3(2):242-9. doi: 10.3945/an.111.001263.
- BackgroundAshworth A., Community-Based Rehabilitation of Severely Malnourished Children: a Review of Successful Programmes. London School of Hygiene and Tropical Medicine. Report. 2001
- Background: PubMed 25432212Dasgupta R, Sinha D, Yumnam V. Programmatic response to malnutrition in India, room for more than one elephant. Indian Pediatr. 2014 Nov;51(11):863-8. doi: 10.1007/s13312-014-0518-5.
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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.
Vibhawari Dani, MBBS; MD principal investigator
Research Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAHAN RUTF & MAHAN Vit-Min mix in people with Child Nutrition Disorders and Malnutrition, run by MAHAN Trust at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 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 2 Feb 2016. 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 India. 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?
Recovery rate of SAM (Severe Acute Malnutrition), SUW (Severe Underweight) and IAP Grade III,IV (time frame: At the end of therapeutic cycle of 3 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 NCT02671786, which also lists 16 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 2 Feb 2016.