Comparison of DASH With Oxalate Restricted Diet on Urine in Recurrent Stone Formers With Hyperoxaluria
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Purpose
Oxalate restricted diet is routinely prescribed in clinical practice of nephrolithiasis patients with hyperoxaluria. The effect of dietary oxalate on urinary oxalate is however controversial. Some studies do not implicate dietary oxalate as a major risk factor for nephrolithiasis. The Dietary Approaches to Stop Hypertension (DASH) diet, which is high in fruits and vegetables, moderate in low-fat dairy products, and low in animal protein represents a novel potential means of kidney stone prevention. The effect of a DASH-style diet on relative urinary supersaturations is however uncertain. Higher consumption of fruits and vegetables may increase urinary oxalate but also increases urinary citrate, an important inhibitor of calcium saturation.All the above data lead us to hypothesize that a DASH diet other than an oxalate restricted diet, which is routinely administered in clinical practice, might be beneficial in lowering urinary relative supersaturations of calcium oxalate in recurrent stone formers with hyperoxaluria.
Recurrent stone formers with hyperoxaluria (urine oxalate>32.8) are allocated into 2 groups. The first group is prescribed an oxalate restricted diet. The second group are asked to follow a calorie-controlled DASH diet plan while drink water in the same amounts. 24-h urine is collected 2 times before study visits at baseline, 1 time on week 6 and 2 times at the end of the study.
| Condition | Intervention |
|---|---|
|
Nephrolithiasis |
Behavioral: diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Study of the Effects of DASH Style Diet and Oxalate Restricted Diet on Urinary Supersaturation Which is a Major Predisposing Factor for Nephrolithiasis |
- urinary oxalate [ Time Frame: 2 months ] [ Designated as safety issue: No ]24-h urine including urine oxalate is collected 2 times before study visits at baseline, and 2 times at the end of the study which is 2 months.
- urinary calcium oxalate supersaturation [ Time Frame: 2 months ] [ Designated as safety issue: No ]Urinary supersaturation is calculated before study visits at baseline, and at the end of the study which is 2 months.
| Enrollment: | 48 |
| Study Start Date: | September 2012 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Oxalate restricted
After a run-in period of 3 weeks patients are allocated into 2 groups. The Oxalate restricted group is prescribed an oxalate restricted diet. They are instructed to avoid oxalate-rich foods such as spinach, rhubarb, beets, chocolate, cereals, nuts, tea, wheat bran, and strawberries and to drink water in amounts of roughly 2 L during cold weather and 3 L during warm/hot weather.
|
Behavioral: diet
When the first set of urine samples confirmed hyperoxaluria (urine oxalate>32.8), the patients will enter the study. After a run-in period of 3 weeks patients are allocated into 2 groups that I already explained in the arms section.The patients are visited in the beginning, after 6 weeks and at the end of the study
|
|
Active Comparator: DASH diet
The second group is asked to follow a calorie-controlled DASH diet plan. DASH is an eating pattern recommended by the 2005 Department of Health and Human Services Dietary Guidelines for Americans as a model of healthy eating for the majority of individuals in the population. This group eats a diet which includes higher fruit, vegetables, and low-fat dairy products and lower in saturated fat, total fat, and cholesterol, containing more whole grains and fewer refined grains, sweets, and red meat.
|
Behavioral: diet
When the first set of urine samples confirmed hyperoxaluria (urine oxalate>32.8), the patients will enter the study. After a run-in period of 3 weeks patients are allocated into 2 groups that I already explained in the arms section.The patients are visited in the beginning, after 6 weeks and at the end of the study
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A history of at least one time kidney stone
- more than 18 years old
- stones at least 50% calcium oxalate
- normal renal function, -sterile urine samples, -
- normal blood pressure
Exclusion Criteria:
- primary hyperoxaluria (urine oxalate>100 mg/24h)
- diabetes mellitus
- hepatic, thyroid, parathyroid, CKD or immunologic disease
Contacts and Locations| Iran, Islamic Republic of | |
| Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences | |
| Tehran, Iran, Islamic Republic of, 1666677951 | |
| Labbafinejad Hospital | |
| Tehran, Iran, Islamic Republic of, 5122 | |
| Principal Investigator: | Nazanin Noori, MD, PhD | urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences |
More Information
No publications provided
| Responsible Party: | Nazanin Noori, MD, PhD, Shaheed Beheshti Medical University |
| ClinicalTrials.gov Identifier: | NCT01650935 History of Changes |
| Other Study ID Numbers: | 114 |
| Study First Received: | July 24, 2012 |
| Last Updated: | April 15, 2013 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Shaheed Beheshti Medical University:
|
Nephrolithiasis Recurrent stone former DASH Urine oxalate Urine calcium oxalate supersaturation |
Additional relevant MeSH terms:
|
Nephrolithiasis Kidney Diseases Urologic Diseases Urolithiasis |
ClinicalTrials.gov processed this record on May 21, 2013