← Back to Search

Dietary Supplement

Diet Modification for Chronic Kidney Disease (ReDACKD Trial)

Phase 1

Recruiting

Led By Navdeep Tangri, MD, PhD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants who have an eGFR between 15 and 40 ml/min/1.73m2

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline,1, 3, 6, 9, and 12 months

Awards & highlights

ReDACKD Trial Summary

This trial is testing whether fruit and vegetables can help manage metabolic acidosis, a common problem in people with chronic kidney disease.

Who is the study for?

The ReDACKD trial is for adults with chronic kidney disease who are not pregnant, haven't had a recent heart attack or stroke, and don't have severe heart failure or lung disease requiring oxygen. They should be able to eat fruits and vegetables without difficulty, have certain levels of blood markers within specific ranges, and not be on dialysis.Check my eligibility

What is being tested?

This study tests if eating alkalizing fruits and vegetables can manage metabolic acidosis better than the usual treatment with sodium bicarbonate pills in people with chronic kidney disease. Participants will receive these foods delivered to their homes to see if this approach improves their condition.See study design

What are the potential side effects?

While the trial's main focus is on dietary changes rather than medication, potential side effects may include discomfort from increased fruit and vegetable intake such as bloating or gas. Sodium bicarbonate can cause stomach upset, nausea, or swelling due to fluid retention.

ReDACKD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney function, measured by eGFR, is between 15 and 40.

ReDACKD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline,1, 3, 6, 9, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline,1, 3, 6, 9, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,1, 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Eligibility to randomization ratio

Potential renal acid load (PRAL) in mEq/day

Study outcome follow up

+1 more

Secondary outcome measures

Albumin

All cause hospitalization

All cause mortality

+20 more

Other outcome measures

All cause hospitalization and all cause mortality

Treatment discontinuation rate

ReDACKD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Alkalizing Fruit and VegetablesExperimental Treatment1 Intervention

Participants randomized to fruit and vegetables (F+V) will receive weekly supplementation of alkalizing fruits and vegetables via home delivery in a box format. Participants will receive a 1-hour dietary counseling session in the first week from a registered dietitian (RD), either in person or via videoconference, depending on regional coronavirus disease (COVID) 19 restrictions and participant preference, which will outline the concepts of the dietary intervention. The RD will also recommend the best ways to prepare and include the F+V into the participant's current diet. Intervention will last 12 months.

Group II: Sodium BicarbonateActive Control1 Intervention

Participants randomized to the alkali therapy will receive oral sodium bicarbonate 500mg tablets three times a day, reflecting a common starting dose at clinical practice. Thereafter, decisions around dose titration for the sodium bicarbonate will then be transferred to the participant's nephrologist who will be responsible for monitoring the participants serum bicarbonate concentration with a goal of maintaining a serum bicarbonate level >22 mEq/L. Participants will receive counselling from a registered dietician (RD) as part of the standard care. Intervention will last 12 months.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor

595 Previous Clinical Trials

199,486 Total Patients Enrolled

Dalhousie UniversityOTHER

167 Previous Clinical Trials

403,098 Total Patients Enrolled

Mount Saint Vincent UniversityOTHER

21 Previous Clinical Trials

2,183 Total Patients Enrolled

Media Library

Alkalizing Fruit and Vegetables (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05113641 — Phase 1

Chronic Kidney Disease Research Study Groups: Alkalizing Fruit and Vegetables, Sodium Bicarbonate

Chronic Kidney Disease Clinical Trial 2023: Alkalizing Fruit and Vegetables Highlights & Side Effects. Trial Name: NCT05113641 — Phase 1

Alkalizing Fruit and Vegetables (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05113641 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have researchers previously explored the benefits of alkalizing fruits and vegetables?

"Presently, 20 studies involving Alkalizing Fruit and Vegetables are in progress with 1 of those trials at Phase 3. Although the bulk of these investigations take place in Decatur, Georgia, there are 29 locations actively conducting research on this potential therapy."

Answered by AI

What is the upper-limit of participants in this research trial?

"This trial is not presently accepting new patients, though it was initially posted on December 1st 2022 and most recently amended October 31st 2022. If you are scouting for more studies to join, there are currently 511 clinical trials actively enrolling those with metabolic acidosis, as well as 20 investigations concerning alkalizing fruit and vegetables that need participants."

Answered by AI

How is the ingestion of Alkalizing Fruit and Vegetables typically utilized to benefit patients?

"Alkalizing Fruit and Vegetables can help barbiturate patients manage their condition, as well as those afflicted by helicobacter infections, acute diarrhoea, and dental plaque."

Answered by AI

What are the expected outcomes of this clinical experiment?

"This 12-month clinical trial intends to measure Serum bicarbonate concentration milliequivalents per liter (mEq/L). Secondary indicators they are tracking include Hemoglobin A1c in percentage, Total blood glucose concentration in mmol/L, and All cause mortality which will be collated from patient records."

Answered by AI

Is enrollment for this experiment currently underway?

"Data hosted on clinicaltrials.gov reveals that this medical trial is not recruiting patients at present; it was initially posted on December 1st, 2022 and its most recent update occurred on October 31st of the same year. Nonetheless, there are 531 other trials presently searching for participants to join their study."

Answered by AI

What potential health hazards are associated with consuming alkaline fruits and vegetables?

"In terms of safety, Alkalizing Fruit and Vegetables has only been tested in Phase 1 clinical trials. As such, our team at Power ascribes a rating of 1 to this food product."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Dietary Acid With Food Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD)

2023. "Reducing Dietary Acid With Food Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05113641.

All > Chronic Kidney Disease