Status:
RECRUITING
Nirvana Super Pro Supplementation in Orthopedic Surgery Patients
Lead Sponsor:
Nirvana Water Sciences Corp
Conditions:
Arthropathy of Knee
Arthropathy of Hip
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
The purpose of this study is to investigate orthopedic patients undergoing either a total hip replacement (THR) or total knee arthroplasty (TKR) using two dietary supplements, PREPARE and RECOVER, and...
Detailed Description
This study involves two dietary supplements that have been formulated by Nirvana Water Sciences Corp for Super Inspired LLC. A pre-operative supplement, called PREPARE, has been created with HMB, Vita...
Eligibility Criteria
Inclusion
- Male and female subjects will be enrolled into the study.
- Age ≥45-80 years.
- Free of liver and kidney diseases, and with no evidence of uncontrolled hypertension.
- Does not have a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
- Not classified as morbidly obese (body mass index (BMI) \>43 kg/m2).
- Six weeks since major surgery (three weeks since minor surgery).
- Total joint replacement is not a revision of previous joint replacement.
- Willing to consume dietary supplements for the study period.
- Individuals diagnosed with osteoporosis, or a bone density \>2.0 standard deviations below the mean, will not be enrolled in the study.
- No other serious medical illness.
- Physicians have placed no restriction on physical exercise.
- Patient is scheduled for a total knee or hip replacement and agrees to consume the 28-day pre-operative regime.
Exclusion
- Evidence of liver and kidney diseases, uncontrolled hypertension, or Type I or II diabetes mellitus requiring insulin for glucose control.
- The presence of a chronic disease that affects calcium or bone metabolism (i.e., asthma with chronic use of high dose steroids, inflammatory bowel disease, Crohn's disease, primary hyperparathyroidism, seizure disorder with use of phenobarbital, etc.).
- Classified as morbidly obese (body mass index (BMI) \>43 kg/m2).
- Less than six weeks since major surgery or three weeks since minor surgery.
- Surgery is a revision of a previous total joint replacement.
- Not willing to consume nutritional supplements for the study period.
- Individuals diagnosed with osteoporosis, or a bone density \>2.0 standard deviations below the mean, will not be enrolled in the study.
- Other serious medical illness, which the subject's doctor or medical review team has decided affects the subject's ability to participate in the study. For example, pathological hip fracture or cancer disease in active phase or undergoing treatment (radiotherapy or chemotherapy).
- History of blood clots and/or the use of blood thinning medications
- Subjects on high dose vitamin D therapies (i.e., 50,000 IU vitamin D).
Key Trial Info
Start Date :
February 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06203691
Start Date
February 21 2024
End Date
August 30 2024
Last Update
March 27 2024
Active Locations (1)
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1
University Orthopedics Center
Altoona, Pennsylvania, United States, 16602