CKDNCT03832166
Reducing Chronic Kidney Disease Burden in an Underserved Population
A study testing Fruits and Vegetables and Cooking in people with CKD and ESRD, run by Baylor Research Institute at 1 site in United States.
Trial summary
To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Fruits and Vegetables and Cooking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2019to 14 Jul 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate in 6 month F\&V study
- Positive urine dipstick.
- African American (self declared) race
- Access to internet via personal computer or mobile device
- Ability to read and write in English
Who cannot join
- Negative urine dipstick
- Currently receiving dialysis or needing dialysis (stage 5 Kidney disease)
- Have received or need kidney transplant
- Pregnant or plan to become pregnant in the next 6 months
- Baseline urine potassium > 60 mEq/g creatinine
- Nephrotic proteinuria demonstrated on urine ACR measurement
- Lacking access to the internet via personal computer or mobile device
- Unable to read or write in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized Two Group Study to Evaluate the Feasibility and Initial Efficacy of a Community-engaged Screening, Identification, and F&V Intervention to Improve F&V Intake and CKD Outcomes in 140 AA Adults
To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems. This novel study will evaluate the feasibility and preliminary efficacy of providing F\&V to individuals identified at high risk study for CKD and ESRD through community health screenings. Further, it will evaluate whether providing education as to how to prepare F\&V for consumption, the latter being done for all F\&V recipients in PI's preliminary published studies but its efficacy was not specifically tested, increases F\&V intake and thereby reduces CKD progression risk as well as related clinical outcomes.
Read the detailed description
"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and F\&V intervention to improve CKD outcomes in 140 AA adults (greater than 18 years). Participants will be randomized to a 1) F\&V only (F\&V Only), or 2) F\&V plus a nutrition/cooking program (F\&V + Cook).
- Being tested
- Fruits and Vegetables, Cooking
- Keywords
- CKD, Low Income, Diet, Fruits and Vegetables
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruits and VegetablesOther
Fruits and vegetables delivery, once/week for 24 weeks
CookingOther
Also called The Happy Kitchen
Nutrition education and cooking instruction class, one class/week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fruits and Vegetables Only | Experimental | This group will receive a prescribed amount of free fruits and vegetables (F \& V) for 6 weeks through pick-up at a farm stand, or direct delivery. After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F\&V at farm stands for an additional 18 weeks with minimal contact Receives: Other: Fruits and Vegetables |
| Fruits and Vegetables and Cook | Experimental | In addition to the prescribed amount of free F\&V, participants will receive 6 weekly, group nutrition and cooking education classes based on "The Happy Kitchen" curriculum. Participants will also receive free ingredients to complete the recipe from each weekly session at home. Receives: Other: Fruits and Vegetables; Other: Cooking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
Primary surrogate marker of eGFR
Measured: Baseline; 6 weeks; 6 months
Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
Measure of renal damage
Measured: Baseline; 6 weeks; 6 months
Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months
Track changes in fruit and vegetable intake via ASA24 food diary
Measured: Baseline; 6 weeks; 6 months
Changes from baseline in dietary fat intake at 6 weeks and 6 months
Track changes in fat (g) intake via ASA24 food diary
Measured: Baseline; 6 weeks; 6 months
Changes from baseline in caloric intake at 6 weeks and 6 months
Track changes in total caloric(kcal) intake via ASA24 food diary
Measured: Baseline; 6 weeks; 6 months
Secondary outcomes (5)
Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months
Measure changes in systolic/diastolic blood pressure (mm Hg) to assess cardiovascular disease risk (CVD)
Measured: Baseline; 6 weeks; 6 months
Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months
Measure changes in total cholesterol, HDL, and LDL (mg/dL) by fingerstick to assess CVD risk
Measured: Baseline; 6 weeks; 6 months
Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months
Measure changes in HgA1C (mg/dL) by fingerstick as a marker of diabetes and to assess CVD risk
Measured: Baseline; 6 weeks; 6 months
Changes from baseline in Blood glucose at 6 weeks and 6 months
Measure fasting glucose(mg/dL) as a marker of diabetes and to assess CVD risk
Measured: Baseline; 6 weeks; 6 months
Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months
Measure body mass index(lb/inches squared) to assess CVD risk
Measured: Baseline; 6 weeks; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start24 Jan 2019
- Primary completion13 Jun 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for CKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized two group study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald Wesson, MD, MBA, Principal investigator, Baylor RI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832166
- Sponsor's protocol ID
- 1R21DK113440-01A1
- Status last verified
- Jul 2020
- First submitted
- 1 Feb 2019
- Last updated
- 27 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Mendu ML, Erickson KF, Hostetter TH, Winkelmayer WC, Olan G, Meyer RN, Hakim R, Sedor JR. Federal Funding for Kidney Disease Research: A Missed Opportunity. Am J Public Health. 2016 Mar;106(3):406-7. doi: 10.2105/AJPH.2015.303009. No abstract available.
PubMed 26885959System USRD. Annual Data Report 2015: Epidemiology of Kidney Disease in the United States. Washington DC: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2015
Ojo A. Addressing the global burden of chronic kidney disease through clinical and translational research. Trans Am Clin Climatol Assoc. 2014;125:229-43; discussion 243-6.
PubMed 25125737Assari S. Distal, intermediate, and proximal mediators of racial disparities in renal disease mortality in the United States. J Nephropathol. 2016 Jan;5(1):51-9. doi: 10.15171/jnp.2016.09. Epub 2015 Dec 4.
PubMed 27047811Hsu CY, Lin F, Vittinghoff E, Shlipak MG. Racial differences in the progression from chronic renal insufficiency to end-stage renal disease in the United States. J Am Soc Nephrol. 2003 Nov;14(11):2902-7. doi: 10.1097/01.asn.0000091586.46532.b4.
PubMed 14569100Genovese G, Friedman DJ, Ross MD, Lecordier L, Uzureau P, Freedman BI, Bowden DW, Langefeld CD, Oleksyk TK, Uscinski Knob AL, Bernhardy AJ, Hicks PJ, Nelson GW, Vanhollebeke B, Winkler CA, Kopp JB, Pays E, Pollak MR. Association of trypanolytic ApoL1 variants with kidney disease in African Americans. Science. 2010 Aug 13;329(5993):841-5. doi: 10.1126/science.1193032. Epub 2010 Jul 15.
PubMed 20647424Freedman BI, Skorecki K. Gene-gene and gene-environment interactions in apolipoprotein L1 gene-associated nephropathy. Clin J Am Soc Nephrol. 2014 Nov 7;9(11):2006-13. doi: 10.2215/CJN.01330214. Epub 2014 Jun 5.
PubMed 24903390Parsa A, Kao WH, Xie D, Astor BC, Li M, Hsu CY, Feldman HI, Parekh RS, Kusek JW, Greene TH, Fink JC, Anderson AH, Choi MJ, Wright JT Jr, Lash JP, Freedman BI, Ojo A, Winkler CA, Raj DS, Kopp JB, He J, Jensvold NG, Tao K, Lipkowitz MS, Appel LJ; AASK Study Investigators; CRIC Study Investigators. APOL1 risk variants, race, and progression of chronic kidney disease. N Engl J Med. 2013 Dec 5;369(23):2183-96. doi: 10.1056/NEJMoa1310345. Epub 2013 Nov 9.
PubMed 24206458Goraya N, Simoni J, Jo C, Wesson DE. Dietary acid reduction with fruits and vegetables or bicarbonate attenuates kidney injury in patients with a moderately reduced glomerular filtration rate due to hypertensive nephropathy. Kidney Int. 2012 Jan;81(1):86-93. doi: 10.1038/ki.2011.313. Epub 2011 Aug 31.
PubMed 21881553Goraya N, Simoni J, Jo CH, Wesson DE. A comparison of treating metabolic acidosis in CKD stage 4 hypertensive kidney disease with fruits and vegetables or sodium bicarbonate. Clin J Am Soc Nephrol. 2013 Mar;8(3):371-81. doi: 10.2215/CJN.02430312. Epub 2013 Feb 7.
PubMed 23393104Goraya N, Simoni J, Jo CH, Wesson DE. Treatment of metabolic acidosis in patients with stage 3 chronic kidney disease with fruits and vegetables or oral bicarbonate reduces urine angiotensinogen and preserves glomerular filtration rate. Kidney Int. 2014 Nov;86(5):1031-8. doi: 10.1038/ki.2014.83. Epub 2014 Apr 2.
PubMed 24694986Navaneethan SD, Schold JD, Arrigain S, Jolly SE, Nally JV Jr. Cause-Specific Deaths in Non-Dialysis-Dependent CKD. J Am Soc Nephrol. 2015 Oct;26(10):2512-20. doi: 10.1681/ASN.2014101034. Epub 2015 Jun 4.
PubMed 26045089Honeycutt AA, Segel JE, Zhuo X, Hoerger TJ, Imai K, Williams D. Medical costs of CKD in the Medicare population. J Am Soc Nephrol. 2013 Sep;24(9):1478-83. doi: 10.1681/ASN.2012040392. Epub 2013 Aug 1.
PubMed 23907508Banks J, Marmot M, Oldfield Z, Smith JP. Disease and disadvantage in the United States and in England. JAMA. 2006 May 3;295(17):2037-45. doi: 10.1001/jama.295.17.2037.
PubMed 16670412So BH, Methven S, Hair MD, Jardine AG, MacGregor MS. Socio-economic status influences chronic kidney disease prevalence in primary care: a community-based cross-sectional analysis. Nephrol Dial Transplant. 2015 Jun;30(6):1010-7. doi: 10.1093/ndt/gfu408. Epub 2015 Jan 13.
PubMed 25586406
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Two Group Study to Evaluate the Feasibility and Initial Efficacy of a Community-engaged Screening, Identification, and F&V Intervention to Improve F&V Intake and CKD Outcomes in 140 AA Adults
- ClinicalTrials.gov ID
- NCT03832166
- Acronym / sponsor ID
- 1R21DK113440-01A1
- Keywords
- CKD, Low Income, Diet, Fruits and Vegetables
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 13 Jun 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 6 Feb 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.
To evaluate a scalable population health strategy to 1) screen, 2) identify, and 3) intervene with individuals at high risk of CKD progression to ESRD that could be implemented in other high risk communities and health care systems. This novel study will evaluate the feasibility and preliminary efficacy of providing F\&V to individuals identified at high risk study for CKD and ESRD through community health screenings. Further, it will evaluate whether providing education as to how to prepare F\&V for consumption, the latter being done for all F\&V recipients in PI's preliminary published studies but its efficacy was not specifically tested, increases F\&V intake and thereby reduces CKD progression risk as well as related clinical outcomes.
Detailed description
"Fruits and Veggies for Health" is a prospective, randomized two group study to evaluate a community-engaged screening, identification, and F\&V intervention to improve CKD outcomes in 140 AA adults (greater than 18 years). Participants will be randomized to a 1) F\&V only (F\&V Only), or 2) F\&V plus a nutrition/cooking program (F\&V + Cook).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized two group study
| Arm | Type | Receives |
|---|---|---|
| Fruits and Vegetables Only | Experimental | Other: Fruits and VegetablesThis group will receive a prescribed amount of free fruits and vegetables (F \& V) for 6 weeks through pick-up at a farm stand, or direct delivery. After 6 weekly pick-up/deliveries, participants will be provided vouchers and reminders to obtain F\&V at farm stands for an additional 18 weeks with minimal contact |
| Fruits and Vegetables and Cook | Experimental | Other: Fruits and Vegetables, Other: CookingIn addition to the prescribed amount of free F\&V, participants will receive 6 weekly, group nutrition and cooking education classes based on "The Happy Kitchen" curriculum. Participants will also receive free ingredients to complete the recipe from each weekly session at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willingness to participate in 6 month F\&V study
- Positive urine dipstick.
- African American (self declared) race
- Access to internet via personal computer or mobile device
- Ability to read and write in English
Key exclusion criteria (8 listed)
- Negative urine dipstick
- Currently receiving dialysis or needing dialysis (stage 5 Kidney disease)
- Have received or need kidney transplant
- Pregnant or plan to become pregnant in the next 6 months
- Baseline urine potassium > 60 mEq/g creatinine
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 |
|---|---|---|
| Fruits and VegetablesFruits and vegetables delivery, once/week for 24 weeks | Other | Fruits and Vegetables Only, Fruits and Vegetables and Cook |
| CookingAlso: The Happy KitchenNutrition education and cooking instruction class, one class/week for 6 weeks | Other | Fruits and Vegetables and Cook |
Primary outcome
Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 months
Primary surrogate marker of eGFR
Change from baseline of Urine albumin-to-creatinine ratio (ACR) at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 months
Measure of renal damage
Changes from baseline in fruit and vegetable intake at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 months
Track changes in fruit and vegetable intake via ASA24 food diary
Changes from baseline in dietary fat intake at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 months
Track changes in fat (g) intake via ASA24 food diary
Changes from baseline in caloric intake at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 months
Track changes in total caloric(kcal) intake via ASA24 food diary
5 secondary outcomes
Changes from baseline in systolic and diastolic Blood pressure at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 months
Changes from baseline in serum Lipoprotein levels at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 months
Changes from baseline in serum Glycosolated hemoglobin A1C (HgA1C) levels at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 months
Changes from baseline in Blood glucose at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 months
Changes from baseline in Body mass index (BMI) at 6 weeks and 6 months
Time frame: Baseline; 6 weeks; 6 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 27 Nov 2020.
- Background: PubMed 26885959Mendu ML, Erickson KF, Hostetter TH, Winkelmayer WC, Olan G, Meyer RN, Hakim R, Sedor JR. Federal Funding for Kidney Disease Research: A Missed Opportunity. Am J Public Health. 2016 Mar;106(3):406-7. doi: 10.2105/AJPH.2015.303009. No abstract available.
- BackgroundSystem USRD. Annual Data Report 2015: Epidemiology of Kidney Disease in the United States. Washington DC: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2015
- Background: PubMed 25125737Ojo A. Addressing the global burden of chronic kidney disease through clinical and translational research. Trans Am Clin Climatol Assoc. 2014;125:229-43; discussion 243-6.
- Background: PubMed 27047811Assari S. Distal, intermediate, and proximal mediators of racial disparities in renal disease mortality in the United States. J Nephropathol. 2016 Jan;5(1):51-9. doi: 10.15171/jnp.2016.09. Epub 2015 Dec 4.
- Background: PubMed 14569100Hsu CY, Lin F, Vittinghoff E, Shlipak MG. Racial differences in the progression from chronic renal insufficiency to end-stage renal disease in the United States. J Am Soc Nephrol. 2003 Nov;14(11):2902-7. doi: 10.1097/01.asn.0000091586.46532.b4.
- Background: PubMed 20647424Genovese G, Friedman DJ, Ross MD, Lecordier L, Uzureau P, Freedman BI, Bowden DW, Langefeld CD, Oleksyk TK, Uscinski Knob AL, Bernhardy AJ, Hicks PJ, Nelson GW, Vanhollebeke B, Winkler CA, Kopp JB, Pays E, Pollak MR. Association of trypanolytic ApoL1 variants with kidney disease in African Americans. Science. 2010 Aug 13;329(5993):841-5. doi: 10.1126/science.1193032. Epub 2010 Jul 15.
- Background: PubMed 24903390Freedman BI, Skorecki K. Gene-gene and gene-environment interactions in apolipoprotein L1 gene-associated nephropathy. Clin J Am Soc Nephrol. 2014 Nov 7;9(11):2006-13. doi: 10.2215/CJN.01330214. Epub 2014 Jun 5.
- Background: PubMed 24206458Parsa A, Kao WH, Xie D, Astor BC, Li M, Hsu CY, Feldman HI, Parekh RS, Kusek JW, Greene TH, Fink JC, Anderson AH, Choi MJ, Wright JT Jr, Lash JP, Freedman BI, Ojo A, Winkler CA, Raj DS, Kopp JB, He J, Jensvold NG, Tao K, Lipkowitz MS, Appel LJ; AASK Study Investigators; CRIC Study Investigators. APOL1 risk variants, race, and progression of chronic kidney disease. N Engl J Med. 2013 Dec 5;369(23):2183-96. doi: 10.1056/NEJMoa1310345. Epub 2013 Nov 9.
- Background: PubMed 21881553Goraya N, Simoni J, Jo C, Wesson DE. Dietary acid reduction with fruits and vegetables or bicarbonate attenuates kidney injury in patients with a moderately reduced glomerular filtration rate due to hypertensive nephropathy. Kidney Int. 2012 Jan;81(1):86-93. doi: 10.1038/ki.2011.313. Epub 2011 Aug 31.
- Background: PubMed 23393104Goraya N, Simoni J, Jo CH, Wesson DE. A comparison of treating metabolic acidosis in CKD stage 4 hypertensive kidney disease with fruits and vegetables or sodium bicarbonate. Clin J Am Soc Nephrol. 2013 Mar;8(3):371-81. doi: 10.2215/CJN.02430312. Epub 2013 Feb 7.
- Background: PubMed 24694986Goraya N, Simoni J, Jo CH, Wesson DE. Treatment of metabolic acidosis in patients with stage 3 chronic kidney disease with fruits and vegetables or oral bicarbonate reduces urine angiotensinogen and preserves glomerular filtration rate. Kidney Int. 2014 Nov;86(5):1031-8. doi: 10.1038/ki.2014.83. Epub 2014 Apr 2.
- Background: PubMed 26045089Navaneethan SD, Schold JD, Arrigain S, Jolly SE, Nally JV Jr. Cause-Specific Deaths in Non-Dialysis-Dependent CKD. J Am Soc Nephrol. 2015 Oct;26(10):2512-20. doi: 10.1681/ASN.2014101034. Epub 2015 Jun 4.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Donald Wesson, MD, MBA principal investigator
Baylor RI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fruits and Vegetables and Cooking in people with CKD and ESRD, run by Baylor Research Institute at 1 site in United States.
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 5 inclusion and 8 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 27 Nov 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 United States. 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?
Change from baseline concentration of Urine angiotensinogen (AGT) at 6 weeks and 6 months (time frame: Baseline; 6 weeks; 6 months). The study lists 5 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 NCT03832166, which also lists 46 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 27 Nov 2020.