Pathways to Improving Functional Capacity in Older Patients With Chronic Kidney Disease and Cardiovascular Disease

NCT02473705 | Withdrawn DMC

• 1 other identifier: WakeForest
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to study the effect of fish oil and bicarbonate (baking soda) on exercise. In this study fish oil, bicarbonate or both will be compared to placebo to see if study participants increase exercise capacity.

Conditions

Chronic Kidney Disease; Cardiovascular Disease

Keywords

Geriatric; bicarbonate; omega polyunsaturated fatty acids; exercise capacity

Outcome Measures

Primary Outcomes (1)

• Change from Baseline of VO2 peak at 12 weeks

  Treadmill during a graded exercise test to exhaustion using a Ramp protocol

  12 weeks

Study Arms (4)

Fish Oil and Bicarbonate placebo

ACTIVE COMPARATOR

1280mg of fish oil per day and bicarbonate placebo

Dietary Supplement: Fish Oil and Bicarbonate Placebo

Fish Oil Placebo and Bicarbonate

ACTIVE COMPARATOR

fish oil placebo and 1mg of bicarbonate per Kg of body weight per day

Dietary Supplement: Fish Oil Placebo and Bicarbonate

Fish Oil and Bicarbonate

EXPERIMENTAL

1280mg of fish oil per day and 1mg of bicarbonate per Kg of body weight per day

Dietary Supplement: Fish Oil and Bicarbonate

Fish Oil placebo and Bicarbonate placebo

PLACEBO COMPARATOR

Fish oil placebo and Bicarbonate placebo

Dietary Supplement: Fish Oil Placebo and Bicarbonate Placebo

Interventions

Fish Oil and Bicarbonate DIETARY_SUPPLEMENT

1280mg of fish oil per day and 1mg of bicarbonate per Kg of body weight per day

Also known as: Nordic Naturals - Ultimate Omega

Fish Oil and Bicarbonate

Fish Oil and Bicarbonate Placebo DIETARY_SUPPLEMENT

1280mg of fish oil per day and bicarbonate placebo (Methylcellulose)

Also known as: Nordic Naturals - Ultimate Omega

Fish Oil and Bicarbonate placebo

Fish Oil Placebo and Bicarbonate DIETARY_SUPPLEMENT

Fish oil placebo (soybean oil) and 1mg of bicarbonate per Kg of body weight per day

Fish Oil Placebo and Bicarbonate

Fish Oil Placebo and Bicarbonate Placebo DIETARY_SUPPLEMENT

Fish oil placebo (soybean oil) and bicarbonate placebo (Methylcellulose)

Fish Oil placebo and Bicarbonate placebo

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred to Cardiac Rehabilitation after acute coronary syndromes or percutaneous intervention
• Stage III Chronic kidney disease
• Clinically stable with no mobility conditions that preclude safe walking and able to walk
• No contraindications that will prevent measurement of physical ability and exercise capacity including severe arthritis or musculoskeletal disorders
• knee/hip replacement or spinal surgery in past year
• Approved for participation by Principal Investigator
• Not involved in any other research study or undergoing physical therapy
• Able to provide own transportation to study visits and intervention
• Willing to provide written consent

You may not qualify if:

• Currently taking fish oil supplements
• Advanced malignancy or other medical condition with life expectancy less than 2 years or undergoing active chemotherapy or radiation therapy
• Oxygen-dependent chronic obstructive pulmonary disease
• Normal kidney function or advanced chronic kidney disease (glomerular filtration rate \< 20 mL/min/1.73 m2, on dialysis or dialysis anticipated within 6 months)
• Mini-mental state examination score of ≤ 21 or previously diagnosed dementia or cognitive impairment limiting ability to participate in rehabilitation and follow study protocols
• Chronic anemia with hemoglobin \<10 gm/dl for males, \<9 gm/dl for females or acute anemia requiring transfusion
• Significant impairment from a prior stroke or other neurologic disease or injury that would preclude participation
• Severe peripheral arterial disease that is the primary limitation to ambulation
• Medical condition that would limit exercise
• High risk for non-adherence as determined by screening evaluation
• Patients who have undergone renal transplantation
• Currently taking bicarbonate supplementation
• Current or recent (within the last 3 months) participation in an exercise program
• Carbon Dioxide level greater than the middle of the normal range i.e. 27mmol/L and thus predisposing to metabolic alkalosis
• Moderate 2+ or greater lower extremity edema

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health Cardiac Rehab

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Interventions

Fish Oils; Bicarbonates

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

Intervention Hierarchy (Ancestors)

Oils; Lipids; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Anions; Ions; Electrolytes

Study Officials

• Killian Robinson, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 16, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: November 7, 2017

Record last verified: 2016-09

Locations

US (1)