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Trial record 57 of 7861 for:    "Kidney Diseases"

Acid-Base Compensation in Chronic Kidney Disease (ABC)

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ClinicalTrials.gov Identifier: NCT02427594
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to evaluate changes in urine net acid excretion, blood pressure and body chemistry that occur when the dietary acid load is lowered by using a drug/dietary supplement similar to baking soda. This may be important for patients with kidney disease because they may have difficulty removing all of the dietary acid load from the body in the urine. Participants with and without kidney disease will be recruited. Each participant will be fed a controlled diet for one week with sodium bicarbonate and for one week without sodium bicarbonate to evaluate these changes. The investigators will also determine if the effect of dietary acid load reduction is different in patients with kidney disease compared to those without kidney disease.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Sodium bicarbonate Other: Controlled diet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Acid-Base Compensation in Chronic Kidney Disease: Measurement and Physiologic Impact
Study Start Date : April 2015
Actual Primary Completion Date : August 25, 2017
Actual Study Completion Date : August 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Controlled diet first
In this arm participants will first consume a controlled diet plus added table salt (sodium chloride) for one week. They will then consume an identical controlled diet plus sodium bicarbonate for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is <70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).
Drug: Sodium bicarbonate
Drug/dietary supplement is used in a crossover design to lower the nonvolatile acid load of the diet compared to the control period.
Other Name: Baking powder

Other: Controlled diet
Diet without sodium bicarbonate supplementation

Experimental: Sodium bicarbonate first
In this arm participants will first consume a controlled diet plus sodium bicarbonate for one week. They will then consume an identical controlled diet plus added table salt (sodium chloride) for one week. Sodium bicarbonate will be dosed as 2,600 mg divided three times daily if ideal body weight is <70 kg or 3,250 mg divided three times daily if ideal body weight is ≥70 kg. Added table salt will match the sodium content of the sodium bicarbonate dose (i.e. 31 or 39 mEq/day).
Drug: Sodium bicarbonate
Drug/dietary supplement is used in a crossover design to lower the nonvolatile acid load of the diet compared to the control period.
Other Name: Baking powder

Other: Controlled diet
Diet without sodium bicarbonate supplementation




Primary Outcome Measures :
  1. Change in ambulatory blood pressure [ Time Frame: Measured at the end of each week of intervention (i.e. one week apart) ]
    Change in mean 24 hour systolic and diastolic blood pressure comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.

  2. Change in urine net acid excretion [ Time Frame: Urine net acid excretion will be measured at three timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in) ]
    Change in urine net acid excretion comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.


Secondary Outcome Measures :
  1. Change in clinic blood pressure [ Time Frame: Clinic blood pressure will be measured at multiple timepoints over approximately 3 weeks (i.e. 2 weeks of intervention plus one week baseline data collection/run-in) ]
    Change in average of three readings of systolic and diastolic blood pressure will be evaluated comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.

  2. Change in plasma nitric oxide metabolites [ Time Frame: Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks ]
    Change in nitric oxide metabolites comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.


Other Outcome Measures:
  1. Differences in metabolomic profiles [ Time Frame: Measured at the end of each week of intervention (i.e. one week apart) up to 3 weeks ]
    Differences in metabolites will be evaluated comparing the end of the controlled feeding plus sodium bicarbonate period to the end of the controlled feeding plus table salt period.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • estimated glomerular filtration rate ≥30 ml/min/1.73m2
  • serum bicarbonate 20-28 mEq/L

Exclusion Criteria:

  • diabetes mellitus
  • uncontrolled hypertension or recent (<3 weeks) titration of blood pressure medications
  • clinically significant volume overload on screening physical examination
  • selected medical conditions other than kidney disease and hypertension (active cancer, chronic liver failure, moderate to severe COPD, New York Heart Association class 2 or greater congestive heart failure, obstructive sleep apnea requiring nightly continuous positive airway pressure, solid organ transplant)
  • use of alkali supplementation
  • body mass index <18.5 or >40 kg/m2
  • ideal body weight <45.5 kg
  • anemia at screening (hematocrit <29% in participants with kidney disease or <33% in healthy participants)
  • pregnancy or breastfeeding
  • allergies, intolerance or unwillingness to consume foods or supplement provided in feeding menu
  • serum calcium less than 8.6 mg/dl on screening laboratories

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427594


Locations
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United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Julia Scialla Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02427594     History of Changes
Other Study ID Numbers: Pro00058905
K23DK095949 ( U.S. NIH Grant/Contract )
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: April 2017

Keywords provided by Duke University:
Kidney Diseases
Renal Insufficiency, Chronic
Dietary nonvolatile acid load
Blood pressure
Urine net acid excretion

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency