Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD) Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Dylan MacKay
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Randomization to preliminary eligible ratio
研究概览
简要总结
Metabolic acidosis is a common problem that occurs with worsening chronic kidney disease. Dietary acid can build up when the kidneys are not working well. This can be associated with a higher risk of worsening kidney function and death. The usual treatment is a medication called sodium bicarbonate which works to balance the acids in the body. The medication however often does not work and causes side effects. Consumption of alkalizing fruit and vegetables may work as a treatment for metabolic acidosis. This trial is being done to see if fruit and vegetables, provided via home delivery, can become a viable management for metabolic acidosis in patients with chronic kidney disease.
详细描述
Metabolic acidosis is a common complication of advanced chronic kidney disease (CKD). As kidney function declines, the ability to excrete excess dietary acid is reduced. This can lead to the development of metabolic acidosis, an imbalance in the body's acid-base balance. Metabolic acidosis is associated with a higher risk of CKD progression and mortality. Typical treatment includes an oral alkali, such as sodium citrate or sodium bicarbonate. Recent studies have shown that the treatment of metabolic acidosis can reduce the decline in kidney function and potentially prevent progression of CKD to dialysis. Treatment rates with an oral alkali are low because the treatments are ineffective, often poorly tolerated, and may be associated with net harm. Base producing fruit and vegetables are a potential treatment of metabolic acidosis by reducing the dietary contribution to overall acid load that must be managed by the kidneys. A recent systematic review and meta-analysis of clinical trials using oral alkali supplements or reduction in dietary acid intake using fruits and vegetables, when compared to no treatment, usual care or placebo found that these treatments increased serum bicarbonate and slowed the decline of kidney function. Fruit and vegetables are an effective and well-tolerated therapy for the treatment of metabolic acidosis in CKD. While oral alkali therapy has known adverse effects, important limitations also exist in the widespread applicability of fruit and vegetables as a treatment for metabolic acidosis. Only 2 single center randomized trials have examined the efficacy of fruit and vegetables for the management for acidosis. This dual-center trial will be the first randomized trial in Canada to evaluate the feasibility of providing fruit and vegetables via home delivery to patients for the management of metabolic acidosis in CKD. This study will be critical in designing a pan-Canadian phase 3 trial testing the efficacy of alkalizing fruit and vegetable provision on slowing the progression of CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to give informed consent for participation in the trial
- •Male or Female, aged 18 years or above
- •Participants who have an eGFR between 15 and 40 ml/min/1.73m2
- •Two consecutive measurements of serum bicarbonate of 14 to 22 mEq/L
- •Systolic and diastolic blood pressure <160/100 mmHg
- •Serum potassium <5.3 mmol/L
- •Hemoglobin A1c below ≤ 11%
- •Are registered in the nephrology clinic in Winnipeg or Halifax
- •Participants are able to communicate in English and provide written informed consent
排除标准
- •Anuria, dialysis or acute kidney injury/acute kidney failure in the 3 months prior to screening
- •Chronic obstructive pulmonary disease that requires the participant to be on oxygen
- •New York Heart Association Class 3-4 Heart failure symptoms or heart, liver or renal transplant
- •A myocardial infarction or stroke within the last 6 months
- •Unable to consume study treatments or control, such as swallowing or GI issues
- •Participants who have participated in another research trial involving an investigational product in the past 12 weeks
- •Currently on potassium binding therapy
- •Female participant who is pregnant or on lactating
研究组 & 干预措施
Alkalizing Fruit and Vegetables
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 from a registered dietitian (RD), following randomization, 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.
干预措施: Alkalizing Fruit and Vegetables (Dietary Supplement)
Sodium Bicarbonate
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.
干预措施: Sodium bicarbonate (Drug)
结局指标
主要结局
Randomization to preliminary eligible ratio
时间窗: 12 months
Ratio of randomized to preliminary eligible greater, calculated among all patients approached to participate expressed as percentage will be collected at 12 months to investigate fruit and vegetable intervention feasibility. A red, yellow, green framework has been developed as a feasibility metric: green for ratios more than 50%, yellow for ratios 20%-49.9%, and red for ratios less than 20%
Study outcome follow up
时间窗: 12 months
Study outcome follow up expressed as a percentage, will be calculated at 12 months to investigate the fruit and vegetable intervention feasibility. A red, yellow, green feasibility framework has been developed as a feasibility metric: green for ≥ 95% , yellow for 80%-94.9% and red for \<80%.
Weekly recruitment rate
时间窗: 12 months
Number of new participants per weeks of active recruitment. A green, yellow, red feasibility framework has been developed as a feasibility metric: green for ≥ 0.5 , yellow for 0.125-0.49 and red for \< 0.125
Potential renal acid load (PRAL) in mEq/day
时间窗: Baseline, 6, and 12 months
Calculated from average dietary intake assessed by Automated Self-Administered 24-hour Canada (ASA24) dietary recall survey conducted over three days. a red, yellow, green feasibility framework has been developed as a feasibility metric: green for \> 75% , yellow for 50%-75% and red for \<50%.
次要结局
- Calcium(Baseline, 1, 3, 6, 9, and 12 month(s))
- Serum bicarbonate (total CO2)(Baseline, 1, 3, 6, 9, and 12 month(s))
- Diastolic blood pressure in mmHg(Baseline, 1, 3, 6, 9, and 12 months)
- Hemoglobin A1c(Baseline, 1, 3, 6, 9, and 12 month(s))
- Five repetition chair stand time(Baseline, 3, 6, 9, and 12 months)
- Physical function related quality of life(Baseline, 3, 6, 9, and 12 months)
- Albumin(Baseline, 1, 3, 6, 9, and 12 month(s))
- Estimated Glomerular Filtration Rate (eGFR)(Baseline, 1, 3, 6, 9, and 12 month(s))
- Glucose(Baseline, 1, 3, 6, 9, and 12 month(s))
- Potassium(Baseline, 1, 3, 6, 9, and 12 month(s))
- Chloride(Baseline, 1, 3, 6, 9, and 12 month(s))
- Sodium(Baseline, 1, 3, 6, 9, and 12 month(s))
- Phosphorus(Baseline, 1, 3, 6, 9, and 12 month(s))
- Blood Urea Nitrogen (BUN)(Baseline, 1, 3, 6, 9, and 12 month(s))
- Urine Albumin/Creatinine Ratio(Baseline, 1, 3, 6, 9, and 12 month(s))
- Changes in medication(Baseline,1, 3, 6, 9, and 12 months)
- Systolic blood pressure in mmHg(Baseline, 1, 3, 6, 9, and 12 months)
- Edmonton Symptom Assessment System (ESAS) - Revised Renal(Baseline, 3, 6, 9, and 12 months)
- All cause hospitalization(3, 6, 9, and 12 months)
- All cause mortality(3, 6, 9, 12 months)
- Height(Baseline, 3, 6, 9, and 12 months)
- Weight(Baseline, 3, 6, 9, and 12 months)
- Body Mass Index (BMI)(Baseline, 3, 6, 9, and 12 months)
研究者
Dylan MacKay
Assistant Professor
University of Manitoba