Study of Beet Juice for Patients With Sickle Cell Anemia
| Status: | Withdrawn |
|---|---|
| Conditions: | Anemia, Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 19 - 65 |
| Updated: | 8/4/2018 |
| Start Date: | September 2014 |
| End Date: | April 2019 |
Phase 2 Study of Effects of Plasma Nitrite in Sickle Cell Anemia
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.
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.
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.
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.
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
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