Study of Beet Juice for Patients With Sickle Cell Anemia

• Status: Withdrawn
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Kim-Shapiro; Wake Forest University Health Sciences
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Wake Forest University

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