Safety and Efficacy of Plant-based Diets in Hemodialysis Patients



Status:Not yet recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:7/15/2018
Start Date:December 1, 2018
End Date:September 2023
Contact:Senji Lama
Email:Senji.Lama@nyumc.org
Phone:212 263 0744

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The purpose of this proof-of-concept controlled-feeding study is to evaluate the impact of
plant-rich diets, with and without high-potassium fruits and vegetables, on phosphorus and
potassium homeostasis in hemodialysis (HD) patients.


Inclusion Criteria:

- Receiving thrice-weekly outpatient HD treatments for end-stage renal disease

- 3-month mean serum potassium and phosphorus concentrations of >4.5 mEq/L and >4.0
mg/dL, respectively

- No prior episodes of moderate-severe hyperkalemia (potassium ≥6.5 mEq/L) in the past 6
months

- Deemed appropriate for the intervention by the patient's nephrologist, considering the
patient's prognosis, cognition and pending treatments (e.g., kidney transplant)

Exclusion Criteria:

- Change in medications that alter potassium homeostasis (e.g., RAAS inhibitors,
diuretics, beta-blockers) in the last month

- Diagnosed with bowel diseases or syndromes (e.g., bowel obstruction, major GI surgery,
short-bowel syndrome, irritable bowel syndrome, inflammatory bowel disease, chronic
diarrhea)

- Anemic, defined as a serum hemoglobin concentration <9.0 g/dL

- Inadequate dialysis efficacy, defined as a Kt/V of <1.2

- Dietary restrictions (e.g., allergies) or otherwise unable/unwilling to adhere to
study diets (excludes dietary restrictions on high-potassium foods)

- Pregnant or planning to become pregnant during the study
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: David St. Jules, MD
Phone: 212-263-0744
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