Dietary Acid Load, Kidney Function and Disability in Elderly

NCT02691663 | Completed Results DMC

• 2 other identifiers: IRB00034474R21AG051866
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the effect of a bicarbonate supplement on kidney function and physical function.

Conditions

Chronic Kidney Disease; Disability

Keywords

Geriatric; bicarbonate

Outcome Measures

Primary Outcomes (2)

• Blood Bicarbonate

  measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults

  baseline

• Blood Bicarbonate

  measurement taken from a blood sample; measures how much carbon dioxide is in your blood; a normal result is between 23 and 29 millimoles per liter (mmol/L) for adults

  six months post baseline

Secondary Outcomes (22)

• Percentage of Screened Participants Randomized

  baseline

• Percent Adherence: Percentage of Pills Taken

  6 months post baseline

• Carbon Dioxide Blood Test

  baseline

• Carbon Dioxide Blood Test

  six months post baseline

• 400 Meter Walk Time

  baseline

Other Outcomes (3)

• Net Endogenous Acid Production (NEAP)

  6 months post randomization

• Net Endogenous Acid Production (NEAP)

  3 months post randomization

• Net Endogenous Acid Production (NEAP)

  Baseline

Study Arms (2)

Oral bicarbonate supplementation group

ACTIVE COMPARATOR

0.3 meq/kg/day NaHCO3 capsules

Dietary Supplement: Oral bicarbonate supplementation

Placebo group

PLACEBO COMPARATOR

Methylcellulose capsules

Dietary Supplement: Placebo

Interventions

Oral bicarbonate supplementation DIETARY_SUPPLEMENT

Oral bicarbonate supplementation group

Placebo DIETARY_SUPPLEMENT

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 +years of age
• Short physical performance battery (SPPB) score\>3
• Estimated glomerular filtration rate (eGFR) 30-89
• Net endogenous acid production (NEAP) \>=40 mEq/d
• Willing to provide informed consent and agrees to randomization
• Not involved in another intervention study

You may not qualify if:

• Uncontrolled (\>160 mg/dl fasting blood glucose), insulin-dependent diabetes and/or uncontrolled hypertension (Systolic Blood Pressure \>160, Diastolic BP\>100)
• a current diagnosis of psychotic disorder
• take more than 14 alcoholic drinks per week
• plan to relocate out of the study area within the next year
• self-reported inability to walk across a room
• those who reside in nursing homes
• have difficulty communicating with study personnel due to speech or language or hearing problems
• had cancer requiring treatment in the past 1 year
• lung disease requiring regular use of corticosteroids or of supplemental oxygen
• cardiovascular disease (Class III or IV congestive heart failure)
• significant valvular disease, uncontrolled angina
• myocardial infarction, major heart surgery (i.e., valve replacement or bypass surgery) in past 6 months
• stroke, deep vein thrombosis, or pulmonary embolus in the past 6 months, Parkinson's disease or other progressive neurological disorder
• other medical or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention
• clinical judgment concerning safety or noncompliance

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Snezana Petrovic, MD, PhD, FASN
• Organization: Campbell University

spetrovic@campbell.edu

(910) 893-1751

Study Officials

• Snezana Petrovic, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: February 25, 2016
• Study Start: February 1, 2016
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: September 25, 2023
• Results First Posted: September 25, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)