Study of Beet Juice for Patients With Sickle Cell Anemia

NCT ID: NCT02162225

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-04-30

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.

Conditions

Sickle Cell Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

beet juice (Unbeetable)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia Dixon, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Daniel B Kim-Shapiro, PhD

Role: STUDY_DIRECTOR

Wake Forest University

Locations

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

R37HL058091

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Wake-58091

Identifier Type: -

Identifier Source: org_study_id