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Efficacy and Safety of the DASH Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02059811
First received: February 7, 2014
Last updated: October 2, 2014
Last verified: October 2014

February 7, 2014
October 2, 2014
February 2014
August 2014   (final data collection date for primary outcome measure)
Change in office systolic blood pressure [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: Yes ]
A comparison of pre-intervention and post-intervention systolic blood pressure will be completed.
Same as current
Complete list of historical versions of study NCT02059811 on ClinicalTrials.gov Archive Site
Change in serum potassium [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: Yes ]
A comparison of pre-intervention and post-intervention serum potassium will be completed.
Same as current
  • Change in blood pressure [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: Yes ]
    A comparison of pre-intervention and post-intervention office diastolic blood pressure and 24 hour ambulatory systolic and diastolic blood pressure will be completed.
  • Change in markers of kidney function [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: Yes ]
    A comparison of pre-intervention and post-intervention markers of kidney function (creatinine, eGFR, and urine albumin-to-creatinine ratio) will be completed.
  • Change in markers of mineral metabolism [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: No ]
    A comparison of pre-intervention and post-intervention markers of mineral metabolism (calcium, phosphorus, intact parathyroid hormone, and 25-hydroxyvitamin D) will be completed.
  • Change in serum electrolytes [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: No ]
    A comparison of pre-intervention and post-intervention electrolytes (bicarbonate, urea nitrogen) will be completed.
  • Change in fasting glucose [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: No ]
    A comparison of pre-intervention and post-intervention fasting glucose will be completed.
  • Change in 24 hour urinary excretion [ Time Frame: 2 weeks post DASH diet intervention ] [ Designated as safety issue: No ]
    A comparison of pre-intervention and post-intervention urinary excretion of sodium, potassium, urea nitrogen, calcium, phosphorus, magnesium, creatinine, and albumin will be completed.
Same as current
 
Efficacy and Safety of the DASH Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study
Efficacy and Safety of the Dietary Approaches to Stop Hypertension (DASH) Diet in Adults With Moderate Chronic Kidney Disease: Pilot Study

More than two-thirds of US adults with chronic kidney disease (CKD) have uncontrolled hypertension. Both hypertension and CKD are major independent risk factors for cardiovascular disease, which is the leading cause of death in the US. Fortunately, lowering blood pressure to recommended treatment targets not only slows the progression of CKD, but also improves cardiovascular outcomes. Controlling hypertension in this patient population, however, can be quite challenging. A lifestyle modification that effectively reduces blood pressure in both pre-hypertensive and hypertensive adults is the Dietary Approaches to Stop Hypertension (DASH) diet.

The purpose of this pilot study is to (1) determine the extent to which the DASH diet lowers blood pressure in hypertensive adults with moderate chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] 30-59 ml/min/1.73m2) and (2) establish that the DASH diet can be safely consumed by this patient population.

During a 7-day run-in phase, participants will first consume a control diet similar in nutrient composition to the control diet of previous DASH studies. The control diet, which is a diet typical of most Americans, is reduced in servings of fruits, vegetables, low fat dairy products and relatively high in total and saturated fat. Immediately following the run-in phase, participants will receive the DASH diet during a 14-day intervention phase. Both diets will have the same sodium content and caloric intake will be adjusted for each participant to keep weight stable. All study meals and snacks will be provided.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Chronic Kidney Disease
  • Other: DASH Diet
    The DASH diet is a nutritional intervention that is low in cholesterol and saturated fat and emphasizes high intake of the following: fruits, vegetables, low-fat dairy products, whole grains, fiber, and protein derived mostly from plant sources.
  • Other: Control Diet
    The control diet, which is a diet typical of most Americans, is relatively high in total and saturated fat and cholesterol, and low in servings of fruits, vegetables and low fat dairy products.
Experimental: DASH Diet
All participants will be provided a control diet for a 7-day run-in period followed by the DASH dietary intervention for a 14-day intervention period. Participants will consume the largest meal of the day in a supervised setting at the study center and all other meals and snacks will be provided in "to-go" packages. Weight will be held constant by measuring participant weight daily and adjusting caloric content of meals. Adherence will be monitor by review of daily food diaries.
Interventions:
  • Other: DASH Diet
  • Other: Control Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≥18 years old
  • eGFR 30-59 ml/min/1.73m2
  • SBP ≥ 130 mmHg or DBP ≥ 80 mmHg
  • willing to eat one meal on-site 5 days/week

Exclusion Criteria:

  • baseline potassium >4.6 mEq/L while not taking potassium supplements (if potassium is ≥ 5.0 while taking potassium supplements, a potassium of 4.6 or less must be demonstrated off supplements
  • evidence of hyperkalemia (>5.1 mEq/L) within last 6 months
  • ≥ 0.5 mg/dl increase in serum creatinine in past 6 months
  • albumin-to-creatinine ratio > 200 mg/mmol
  • insulin requiring or poorly controlled diabetes mellitus
  • cardiovascular event within previous 6 months
  • change in anti-hypertensive medications in last 2 weeks, or anticipated medication change during study period
  • unwillingness to eat only study food for 21 day study period
  • unwillingness or inability to discontinue vitamin and mineral supplements or antacids containing potassium, magnesium or calcium
  • use of aldosterone antagonist
  • use of oral corticosteroids
  • alcohol intake >14 drinks/week
  • unstable doses of psychotropics or phenothiazine
  • weight reducing medications
  • use of medications for erectile dysfunction during study period
  • pregnant, breast feeding, or planning pregnancy during study period
  • chronic disease that may interfere with participation
  • history of organ transplant
  • any serious illness that would interfere with participation or make DASH diet unsafe
  • planning to leave the area during the study period
  • significant food allergies, preferences, or dietary requirements that would interfere with diet adherence
  • investigator discretion for safety or compliance reasons
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02059811
Pro00048112
No
Duke University
Duke University
Not Provided
Principal Investigator: Crystal Tyson, MD Duke University
Duke University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP