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Study of Beet Juice for Patients With Sickle Cell Anemia

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ClinicalTrials.gov Identifier: NCT02162225
Recruitment Status : Withdrawn (Enrollment was very slow. Hope to reopen as multi-site study)
First Posted : June 12, 2014
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
Wake Forest University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE June 9, 2014
First Posted Date  ICMJE June 12, 2014
Last Update Posted Date August 2, 2018
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
Total Number of Participants with Adverse Events as a Measure of Safety and Tolerability as a function of time [ Time Frame: up to 58 Days ]
Physical symptoms will be assessed either by telephone or in person
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02162225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • Changes in Red blood cell properties as a function of time [ Time Frame: Days 1, 14, 28 ]
    Blood will be drawn and used to measure red blood cell deformability and mean corpuscular hemoglobin concentration
  • Changes in Platelet function as a function of time [ Time Frame: Days 1, 14, 28 ]
    Blood will be drawn and used to measure platelets activation and aggregation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Beet Juice for Patients With Sickle Cell Anemia
Official Title  ICMJE Phase 2 Study of Effects of Plasma Nitrite in Sickle Cell Anemia
Brief Summary The investigators hypothesize that increasing plasma nitrite using dietary nitrate will improve platelet function and red cell deformability and decrease MCHC in patients with sickle cell disease. The investigators will test this hypothesis through administration of daily intake of beetroot juice (Unbeetable - Performance Drink) to patients with sickle cell disease for 28 days. The investigators will evaluate the safety of daily beet root juice intake in patients with sickle cell disease. In addition, the investigators will measure MCHC, red cell deformability, and platelet function (activation and aggregation) in response to daily intake of beet root juice in this patient population.
Detailed Description

Sickle cell disease is caused by dysfunction of a mutant form of hemoglobin which polymerizes under hypoxic conditions, sickling the red blood cell. Sickling makes the cells rigid which contributes to vascular occlusion and much morbidity and mortality. Cycles of sickling and unsickling leads to calcium (Ca) influx which activates the gardos channel which pumps out potassium from the cells. Loss of potassium leads to dehydration, poor deformability, and increased mean corpuscular hemoglobin concentration (MCHC) in red blood cells. Increased MCHC leads to increased polymerization. Thus, a significant therapeutic goal for sickle cell disease has been to decrease MCHC by blocking the Ca-influx induced dehydration.

Rifkind and coworkers have shown that the NO+ donor sodium nitrosoprusside (SNP) can block Ca-induced loss of deformability when normal red blood cells are exposed to Ca and a Ca ionophore. The investigators have preliminary data showing that both NO activity donors SNP and nitrite can partially relieve loss of deformability due to cycles of sickling and unsickling in red cells from patients with sickle cell disease.

Low nitric oxide (NO) bioavailabilty secondary to red cell hemolysis has been proposed to contribute to pathology in sickle cell disease. Low NO could lead to poor protection against Ca-induced potassium loss described above. Another consequence of low NO is likely to be increased platelet activation; sickle cell disease is pro-thrombotic disease. NO reduces platelet aggregation and activation. It has been shown that an acute dietary nitrate intervention can reduce platelet aggregation in healthy volunteers. Nitrate is converted to nitrite which is converted to NO in the body.6 Improved platelet function is likely due to increasing NO bioavailability through the nitrate intervention.

In this pilot study, the safety of Beet Juice intake in patients with sickle cell disease will be evaluated using a self-administered health survey. Physiological effects of the Beet Juice will also be examined and the investigators hypothesize that increasing plasma nitrite using dietary nitrate will improve platelet function and red cell deformability and decrease MCHC in patients with sickle cell disease. The investigators will test this hypothesis through administration of daily intake of Beet Juice to patients with sickle cell disease for 28 days. The investigators will measure MCHC, red cell deformability, and platelet function (activation and aggregation) in response to the intervention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Anemia
Intervention  ICMJE Drug: beet juice (Unbeetable)

Volunteers will drink a single 8 ounce bottle of beet juice (Unbeetable) per day for 28 days.

On days 1,14, and 28, the juice will be drunk just prior to having blood drawn. Blood will also be drawn 1.5 hours after drinking the juice on days 1,14, and 28.

Study Arms  ICMJE Experimental: Beet Juice

Volunteers will drink a single 8 ounce bottle of beet juice (Unbeetable) per day for 28 days.

On days 1,14, and 28, the juice will be drunk just prior to having blood drawn. Blood will also be drawn 1.5 hours after drinking the juice on days 1,14, and 28.

Intervention: Drug: beet juice (Unbeetable)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 31, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
24
Estimated Study Completion Date  ICMJE April 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosis of sickle cell anemia (Hb S/S or Hb S/beta thal0)
  • no acute illness at the time of obtaining the study
  • willingness to adhere to the study preparatory procedures including drinking the beet juice product daily
  • willingness to give consent in order to participate

Exclusion Criteria:

  • less than 19 years in age or older than 65
  • smoke or chew tobacco
  • currently take medications that affect stomach pH
  • atrophic gastritis
  • hypo-or hyperthyroidism
  • Type I or II diabetes
  • history of gout, kidney stones or hypotension
  • pregnant
  • aversion to the study-related testing procedures
  • allergy, sensitivity or aversion to the study beetroot juice beverage
  • suffered an acute sickle cell episode (involving hospitalization or a visit to the emergency room) within the past six months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162225
Other Study ID Numbers  ICMJE Wake-58091
R37HL058091 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE
  • Wake Forest University
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Natalia Dixon, MD Wake Forest University Health Sciences
Study Director: Daniel B Kim-Shapiro, PhD Wake Forest University
PRS Account Wake Forest University Health Sciences
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP