Dietary Nitrate Supplements and Ischemic Stroke Recovery

Completed · Phase 2 · Has a placebo group

Conditions studied: Stroke, Ischemic Stroke, Cerebrovascular Accident

In brief

This is a double-blind, randomized, placebo-controlled, pilot study. Participants will be randomized to receive either beetroot juice or a beetroot juice placebo, as a dietary supplement, for 30 days. Beetroot juice is high in nitrates, a chemical when ingested is found to increase blood flow to the brain. The purpose of this research study is to determine the safety and feasibility of using this nutritional intervention in (ischemic)stroke survivors, and prove that plasma levels of nitrate and nitrite increase as expected. Secondary outcomes includes measuring a comprehensive set of outcomes related to functional status post-stroke, including mobility, upper extremity strength, cognition, depression, and disability. Patients will also be randomized to MRI perfusion scanning in the region of the stroke to measure cerebral blood flow.

Key facts

Study ID

NCT02838901

Run by

Wake Forest University Health Sciences

People needed

18

Starts

2012-06-01

Expected to finish

2016-06-01

Last updated by the study team

2018-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 18 years old and over
• Diagnosed with an ischemic stroke (acute focal neurological deficit resulting from an ischemic cause, verified by CT or MRI)
• Symptom onset within 5 days of admission
• National Institutes of Health Stroke Scale Score of 2 or more (but less than 20)
• A rating of fair or good on static sitting balance scale on a global balance scale
• A score of more that 0 on the hip flexion on the short Fugl-Myer
• Passed dysphagia screening for unrestricted or thickened liquids

You may not qualify if…

• Patients with severe stroke (National Institutes of Health Stroke Scale Score of 20 or more)
• A score of 0 on hip flexion on the Short Fugl-Myer as a result of weakness from the stroke
• A rating of poor on static sitting balance scale on a global balance scale
• Patients who received intravenous or intra-arterial recombinant tissue plasminogen activator (rtPA)
• Patients who are receiving citicoline
• Patients who have had a hemorrhagic stroke (including intraparenchymal, subarachnoid or subdural hemorrhage)
• A gait speed of more > 0.8 m/s
• Patient with evidence of brain tumor or other psychiatric or neurological condition that would interfere with outcome measures
• Patients who will undergo carotid endarterectomy or other surgery during the study period
• Patients not living independently prior to stroke
• Survival is expected to be less than 6 months
• Any patient on organic nitrate-containing medications; some examples of the medications that are exclusions include nitroglycerin, isosorbide mononitrate, sildenafil (Viagra), and tadalafil (Cialis)
• Patients with atrophic gastritis
• Patients with hypotension (blood pressure less than 100/60 mmHg)
• Patients who do not pass the dysphagia screening test

Where it is running

• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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