Vitamin D DeficiencyVISTANCT02212652
Vitamin D to Improve Nutrition Prior to Bariatric Surgery and Investigate the Relationship With Negative Outcomes
A study testing Vitamin D in people with Vitamin D Deficiency and Vitamin D Insufficiency, run by Johns Hopkins University at 1 site in United States.
Trial summary
VISTA is looking to see if vitamin D supplements before bariatric surgery might improve vitamin D stores, which may help to prevent some complications like infections. Who can join this research study? Approved to undergo bariatric surgery-Roux-en-Y Gastric Bypass or Vertical Sleeve Gastrectomy-at the Johns Hopkins… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Vitamin D Deficiency, Vitamin D Insufficiency
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Apr 2017
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients approved for and undergoing clinically indicated bariatric surgery -Roux-en-Y Gastric Bypass (RYGBP) or Vertical Sleeve Gastrectomy (VSG)
- 18 to 64 years of age
- BMI of 35 to 49.9 kg/m2
- VitD insufficient pre-operatively: serum 25(OH)D concentration < 75 nmol/L or 30 ng/ml
Who cannot join
- Any patient who does not want to participate in the study
- Any patient who has dietary restrictions/proscriptions prohibiting ingestion of beef gelatin
- Expected poor compliance with the medical regimen
- Any active medical conditions that could, in the opinion of the investigators, jeopardize the safety of the subject or the integrity of the study
- The elective bariatric surgery is cancelled prior to incision by a surgeon for any reason
- Pregnancy: The routine standard of care is to determine whether a female patient is pregnant either by history and/or urinary pregnancy test on the day of surgery. No additional testing specifically for this study is planned beyond the standard of care.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins Center for Bariatric Surgery
Baltimore, Maryland, 21224
About this study
Official title: The Effect of VItamin D Supplementation on Nutritional STatus and Adverse Outcomes in Bariatric Surgery (VISTA)
VISTA is looking to see if vitamin D supplements before bariatric surgery might improve vitamin D stores, which may help to prevent some complications like infections.
Who can join this research study?
Read more
- Approved to undergo bariatric surgery-Roux-en-Y Gastric Bypass or Vertical Sleeve Gastrectomy-at the Johns Hopkins Bayview Medical Center
- 18 to 64 years of age
- BMI of 35 to 49.9 kg/m2
- VitD insufficient or deficient prior to having surgery
What will happen if a participant chooses to participate in this research study?
- The participant will be randomly assigned (by chance) to receive either:
- Standard care plus vitamin D supplements or
- Standard care plus a placebo (contains no vitamin D)
- Either would be provided at no cost to the participant
- The investigators will ask the participant to complete a survey on the day of surgery regarding supplement use
- The investigators will follow the participants medical record through the 12 month follow up clinic visit.
Read the detailed description
An estimated 2 in 3 American adults are either overweight (BMI 25-29.9 kg/m2) or obese (BMI 30-39.9 kg/m2). The prevalence of obesity, morbid obesity (BMI 40-44.9 kg/m2), and even super obesity (BMI ≥ 45 kg/m2) are increasing. Obesity is a leading contributor to global mortality and contributes to the burden of disease associated with diabetes, cardiovascular disease, musculoskeletal disorders such as osteoarthritis, and some cancers. Morbid obesity reduces life expectancy by 8 to 10 years, similar to the effect of being a regular cigarette smoker.
Several studies have demonstrated that most obese adults are vitamin D (VitD) insufficient (<75 nmol/L, 30 ng/ml) or deficient (<50 nmol/L, 20 ng/ml). The inverse relationship between body mass index (BMI) or body fat mass and VitD status is hypothesized to be due to sequestration of VitD by adipose tissue, reducing the bioavailability of VitD. The classical role of VitD is in the maintenance of bone calcification, but more recent research has elucidated a more varied role for this hormone. Lack of VitD has been associated with increased susceptibility to infection, autoimmunity, cancer, and chronic disease.
Bariatric surgery is currently the most successful means of long-term weight loss. Since deficiency in fat-soluble vitamins, such as VitD, is considered a metabolic complication of bariatric surgery, determining the VitD status of these individuals and perhaps correcting it prior to surgery may prove greatly beneficial. Potential complications relating to VitD insufficiency and deficiency include adverse surgical outcomes such as improper wound healing, infection of the surgical incision, and atrial fibrillation. Since the indications for bariatric surgery are obesity and obesity-related comorbidities, bariatric surgery patients are at an increased risk of having an adverse surgical outcome.
The Johns Hopkins Center for Bariatric Surgery (JHCBS) is designated as a Center of Excellence by the American College of Surgeons. To comply with this designation, the center must maintain a certain standard of care (SoC) and minimize complication rates. Given the potential relationship between VitD status and adverse surgical outcomes, the investigators are currently reviewing pre-operative VitD status (serum 25(OH)D concentration) collected as routine SoC and investigating the relationship with surgical outcomes under an Institutional Review Board (IRB) approved protocol (NA_00087502). The investigators findings reveal that most of bariatric surgery patients are VitD insufficient and deficient pre-operatively. To date, there is no standard regarding treating these deficiencies pre-operatively and as such the center does not intervene prior to surgery. A randomized, double-blinded, placebo-controlled pilot trial is needed to assess the causality of the relationship between pre-operative VitD status and adverse surgical outcomes in the bariatric surgical patient.
The investigators plan to identify new patients approved for bariatric surgery at the JHCBS. These patients will be randomized consecutively in a 1:1 ratio to either 30 days of 10,000 International Units (IU) of VitD3 plus SoC or 30 days of placebo plus SoC immediately prior to surgery. The investigators will monitor these patients for any adverse surgical outcomes, including wound infection, dehiscence, and prolonged length of hospital stay. The investigators will also monitor their long-term clinical outcomes such as malnutrition, weight loss, and resolution of comorbidities at their routine clinic care visit: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months post-operatively. At these visits the patients are assessed for wound healing, weight loss, nutritional status, and other key markers of health, such as vital signs.
The investigators aim to determine if 10,000 IU of VitD3 daily for 30 days prior to bariatric surgery (Roux-en Y Gastric Bypass (RYGB) or Vertical Sleeve Gastrectomy (VSG)) will significantly increase the VitD status (serum 25(OH)D concentration) and whether the associated change in VitD status leads to decrease risk of adverse surgical outcomes and/or improved clinical outcomes.
- Conditions
- Vitamin D Deficiency, Vitamin D Insufficiency
- Being tested
- Vitamin D, Placebo, Standard of Care
- Keywords
- Bariatric surgery, Vitamin D deficiency, Vitamin D insufficiency, Adverse surgical outcomes, Clinical outcomes
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Bariatric Advantage Vitamin D Chewable Gels
10,000 IU of VitD3 daily (one gel daily)
PlaceboOther
Gummy button placebo, which will appear very similar to the vitamin D supplement.
Standard of CareOther
Patients will receive the standard care provided to all patients undergoing bariatric surgery regardless of research study participation status.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care plus Vitamin D | Active comparator | If randomized to this arm, each participant will receive a 30 day supply of 10,000 IU of VitD3 for research purposes in addition to receiving standard of care. We will ask that they take one of these supplements daily with their largest meal of the day until their surgery. Receives: Dietary Supplement: Vitamin D; Other: Standard of Care |
| Standard of Care plus Placebo | Placebo comparator | If randomized to this arm, each participant will receive a 30 day supply of placebo supplements for research purposes in addition to receiving standard of care. We will ask that they take one of these supplements daily with their largest meal of the day until their surgery. Receives: Other: Placebo; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D status as measured by serum 25(OH)D concentration.
Improved post-operative vitamin D status as measured by serum 25(OH)D concentration.
Measured: Up to 12 months after surgery
Secondary outcomes (2)
Adverse surgical outcomes (aggregate)
Adverse surgical outcomes include surgical site infection, wound separation and dehiscence, anastomotic leak, prolonged length of hospital stay (> 3 days), and re-admittance to the hospital within 30 days post-operatively.
Measured: Up to 30 days after surgery
Clinical outcomes (aggregate)
Long-term clinical outcomes include wound healing, weight loss, nutritional status, resolution of comorbidities, and other key markers of health, such as vital signs (fever, blood pressure, heart rate, pain, etc.) and return of a regular menstrual cycle.
Measured: Up to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startJan 2017
- Primary completionApr 2017
- Study completionApr 2017
Why it stopped: lack of support resources to complete study appropriately
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Bariatric Advantage
- Responsible party
- Sponsor
- Investigators
- Kimberley E Steele, MD, PhD, Principal investigator, Johns Hopkins UniversityMichael A. Schweitzer, MD, Study director, Johns Hopkins UniversityThomas H Magnuson, MD, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212652
- Sponsor's protocol ID
- IRB00044789
- Acronym
- VISTA
- Status last verified
- Jun 2019
- First submitted
- 6 Aug 2014
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Quraishi SA, Bittner EA, Blum L, Hutter MM, Camargo CA Jr. Association between preoperative 25-hydroxyvitamin D level and hospital-acquired infections following Roux-en-Y gastric bypass surgery. JAMA Surg. 2014 Feb;149(2):112-8. doi: 10.1001/jamasurg.2013.3176.
PubMed 24284777Goldner WS, Stoner JA, Lyden E, Thompson J, Taylor K, Larson L, Erickson J, McBride C. Finding the optimal dose of vitamin D following Roux-en-Y gastric bypass: a prospective, randomized pilot clinical trial. Obes Surg. 2009 Feb;19(2):173-179. doi: 10.1007/s11695-008-9680-y. Epub 2008 Sep 16.
PubMed 18795378Lin E, Armstrong-Moore D, Liang Z, Sweeney JF, Torres WE, Ziegler TR, Tangpricha V, Gletsu-Miller N. Contribution of adipose tissue to plasma 25-hydroxyvitamin D concentrations during weight loss following gastric bypass surgery. Obesity (Silver Spring). 2011 Mar;19(3):588-94. doi: 10.1038/oby.2010.239. Epub 2010 Oct 14.
PubMed 20948527Nguyen S, Baggerly L, French C, Heaney RP, Gorham ED, Garland CF. 25-Hydroxyvitamin D in the range of 20 to 100 ng/mL and incidence of kidney stones. Am J Public Health. 2014 Sep;104(9):1783-7. doi: 10.2105/AJPH.2013.301368. Epub 2013 Oct 17.
PubMed 24134366
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of VItamin D Supplementation on Nutritional STatus and Adverse Outcomes in Bariatric Surgery (VISTA)
- ClinicalTrials.gov ID
- NCT02212652
- Acronym / sponsor ID
- VISTA / IRB00044789
- Conditions
- Vitamin D Deficiency, Vitamin D Insufficiency
- Keywords
- Bariatric surgery, Vitamin D deficiency, Vitamin D insufficiency, Adverse surgical outcomes, Clinical outcomes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of support resources to complete study appropriately
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Bariatric Advantage
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Aug 2014 (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.
VISTA is looking to see if vitamin D supplements before bariatric surgery might improve vitamin D stores, which may help to prevent some complications like infections.
Who can join this research study?
- Approved to undergo bariatric surgery-Roux-en-Y Gastric Bypass or Vertical Sleeve Gastrectomy-at the Johns Hopkins Bayview Medical Center
- 18 to 64 years of age
- BMI of 35 to 49.9 kg/m2
- VitD insufficient or deficient prior to having surgery
What will happen if a participant chooses to participate in this research study?
- The participant will be randomly assigned (by chance) to receive either:
- Standard care plus vitamin D supplements or
- Standard care plus a placebo (contains no vitamin D)
- Either would be provided at no cost to the participant
- The investigators will ask the participant to complete a survey on the day of surgery regarding supplement use
- The investigators will follow the participants medical record through the 12 month follow up clinic visit.
Detailed description
An estimated 2 in 3 American adults are either overweight (BMI 25-29.9 kg/m2) or obese (BMI 30-39.9 kg/m2). The prevalence of obesity, morbid obesity (BMI 40-44.9 kg/m2), and even super obesity (BMI ≥ 45 kg/m2) are increasing. Obesity is a leading contributor to global mortality and contributes to the burden of disease associated with diabetes, cardiovascular disease, musculoskeletal disorders such as osteoarthritis, and some cancers. Morbid obesity reduces life expectancy by 8 to 10 years, similar to the effect of being a regular cigarette smoker.
Several studies have demonstrated that most obese adults are vitamin D (VitD) insufficient (<75 nmol/L, 30 ng/ml) or deficient (<50 nmol/L, 20 ng/ml). The inverse relationship between body mass index (BMI) or body fat mass and VitD status is hypothesized to be due to sequestration of VitD by adipose tissue, reducing the bioavailability of VitD. The classical role of VitD is in the maintenance of bone calcification, but more recent research has elucidated a more varied role for this hormone. Lack of VitD has been associated with increased susceptibility to infection, autoimmunity, cancer, and chronic disease.
Bariatric surgery is currently the most successful means of long-term weight loss. Since deficiency in fat-soluble vitamins, such as VitD, is considered a metabolic complication of bariatric surgery, determining the VitD status of these individuals and perhaps correcting it prior to surgery may prove greatly beneficial. Potential complications relating to VitD insufficiency and deficiency include adverse surgical outcomes such as improper wound healing, infection of the surgical incision, and atrial fibrillation. Since the indications for bariatric surgery are obesity and obesity-related comorbidities, bariatric surgery patients are at an increased risk of having an adverse surgical outcome.
The Johns Hopkins Center for Bariatric Surgery (JHCBS) is designated as a Center of Excellence by the American College of Surgeons. To comply with this designation, the center must maintain a certain standard of care (SoC) and minimize complication rates. Given the potential relationship between VitD status and adverse surgical outcomes, the investigators are currently reviewing pre-operative VitD status (serum 25(OH)D concentration) collected as routine SoC and investigating the relationship with surgical outcomes under an Institutional Review Board (IRB) approved protocol (NA_00087502). The investigators findings reveal that most of bariatric surgery patients are VitD insufficient and deficient pre-operatively. To date, there is no standard regarding treating these deficiencies pre-operatively and as such the center does not intervene prior to surgery. A randomized, double-blinded, placebo-controlled pilot trial is needed to assess the causality of the relationship between pre-operative VitD status and adverse surgical outcomes in the bariatric surgical patient.
The investigators plan to identify new patients approved for bariatric surgery at the JHCBS. These patients will be randomized consecutively in a 1:1 ratio to either 30 days of 10,000 International Units (IU) of VitD3 plus SoC or 30 days of placebo plus SoC immediately prior to surgery. The investigators will monitor these patients for any adverse surgical outcomes, including wound infection, dehiscence, and prolonged length of hospital stay. The investigators will also monitor their long-term clinical outcomes such as malnutrition, weight loss, and resolution of comorbidities at their routine clinic care visit: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months post-operatively. At these visits the patients are assessed for wound healing, weight loss, nutritional status, and other key markers of health, such as vital signs.
The investigators aim to determine if 10,000 IU of VitD3 daily for 30 days prior to bariatric surgery (Roux-en Y Gastric Bypass (RYGB) or Vertical Sleeve Gastrectomy (VSG)) will significantly increase the VitD status (serum 25(OH)D concentration) and whether the associated change in VitD status leads to decrease risk of adverse surgical outcomes and/or improved clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care plus Vitamin D | Active comparator | Dietary Supplement: Vitamin D, Other: Standard of CareIf randomized to this arm, each participant will receive a 30 day supply of 10,000 IU of VitD3 for research purposes in addition to receiving standard of care. We will ask that they take one of these supplements daily with their largest meal of the day until their surgery. |
| Standard of Care plus Placebo | Placebo comparator | Other: Placebo, Other: Standard of CareIf randomized to this arm, each participant will receive a 30 day supply of placebo supplements for research purposes in addition to receiving standard of care. We will ask that they take one of these supplements daily with their largest meal of the day until their surgery. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients approved for and undergoing clinically indicated bariatric surgery -Roux-en-Y Gastric Bypass (RYGBP) or Vertical Sleeve Gastrectomy (VSG)
- 18 to 64 years of age
- BMI of 35 to 49.9 kg/m2
- VitD insufficient pre-operatively: serum 25(OH)D concentration < 75 nmol/L or 30 ng/ml
Key exclusion criteria (6 listed)
- Any patient who does not want to participate in the study
- Any patient who has dietary restrictions/proscriptions prohibiting ingestion of beef gelatin
- Expected poor compliance with the medical regimen
- Any active medical conditions that could, in the opinion of the investigators, jeopardize the safety of the subject or the integrity of the study
- The elective bariatric surgery is cancelled prior to incision by a surgeon for any reason
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 |
|---|---|---|
| Vitamin DAlso: Bariatric Advantage Vitamin D Chewable Gels10,000 IU of VitD3 daily (one gel daily) | Dietary supplement | Standard of Care plus Vitamin D |
| PlaceboGummy button placebo, which will appear very similar to the vitamin D supplement. | Other | Standard of Care plus Placebo |
| Standard of CarePatients will receive the standard care provided to all patients undergoing bariatric surgery regardless of research study participation status. | Other | Standard of Care plus Placebo, Standard of Care plus Vitamin D |
Primary outcome
Vitamin D status as measured by serum 25(OH)D concentration.
Time frame: Up to 12 months after surgery
Improved post-operative vitamin D status as measured by serum 25(OH)D concentration.
2 secondary outcomes
Adverse surgical outcomes (aggregate)
Time frame: Up to 30 days after surgery
Clinical outcomes (aggregate)
Time frame: Up to 12 months after surgery
Results and safety
The study was stopped early (reason given: lack of support resources to complete study appropriately). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Background: PubMed 24284777Quraishi SA, Bittner EA, Blum L, Hutter MM, Camargo CA Jr. Association between preoperative 25-hydroxyvitamin D level and hospital-acquired infections following Roux-en-Y gastric bypass surgery. JAMA Surg. 2014 Feb;149(2):112-8. doi: 10.1001/jamasurg.2013.3176.
- Background: PubMed 18795378Goldner WS, Stoner JA, Lyden E, Thompson J, Taylor K, Larson L, Erickson J, McBride C. Finding the optimal dose of vitamin D following Roux-en-Y gastric bypass: a prospective, randomized pilot clinical trial. Obes Surg. 2009 Feb;19(2):173-179. doi: 10.1007/s11695-008-9680-y. Epub 2008 Sep 16.
- Background: PubMed 20948527Lin E, Armstrong-Moore D, Liang Z, Sweeney JF, Torres WE, Ziegler TR, Tangpricha V, Gletsu-Miller N. Contribution of adipose tissue to plasma 25-hydroxyvitamin D concentrations during weight loss following gastric bypass surgery. Obesity (Silver Spring). 2011 Mar;19(3):588-94. doi: 10.1038/oby.2010.239. Epub 2010 Oct 14.
- Background: PubMed 24134366Nguyen S, Baggerly L, French C, Heaney RP, Gorham ED, Garland CF. 25-Hydroxyvitamin D in the range of 20 to 100 ng/mL and incidence of kidney stones. Am J Public Health. 2014 Sep;104(9):1783-7. doi: 10.2105/AJPH.2013.301368. Epub 2013 Oct 17.
- The Johns Hopkins Center for Bariatric SurgeryLink provided by the sponsor.
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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.
Kimberley E Steele, MD, PhD principal investigator
Johns Hopkins University
Michael A. Schweitzer, MD study director
Johns Hopkins University
Thomas H Magnuson, MD study director
Johns Hopkins 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 Vitamin D in people with Vitamin D Deficiency and Vitamin D Insufficiency, run by Johns Hopkins University 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Jun 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 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: lack of support resources to complete study appropriately). Results are not available in the source record.
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?
Vitamin D status as measured by serum 25(OH)D concentration. (time frame: Up to 12 months after surgery). 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 NCT02212652, which also lists 4 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 6 Jun 2019.