Study of Beet Juice for Patients With Sickle Cell Anemia

NCT02162225 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: Wake-58091R37HL058091
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Anemia

Keywords

Erythrocyte Deformability; Platelet Activation; Platelet Aggregation; Nitrite; Sickle Cell Anemia; Diet Therapy

Outcome Measures

Primary Outcomes (1)

• Total Number of Participants with Adverse Events as a Measure of Safety and Tolerability as a function of time

  Physical symptoms will be assessed either by telephone or in person

  up to 58 Days

Secondary Outcomes (2)

• Changes in Red blood cell properties as a function of time

  Days 1, 14, 28

• Changes in Platelet function as a function of time

  Days 1, 14, 28

Study Arms (1)

Beet Juice

EXPERIMENTAL

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.

Drug: beet juice (Unbeetable)

Interventions

beet juice (Unbeetable) 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.

Beet Juice

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Wake Forest University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Natalia Dixon, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Daniel B Kim-Shapiro, PhD

  Wake Forest University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 12, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

US (1)