Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

Status unconfirmed · Not applicable

Conditions studied: Arthropathy of Knee, Arthropathy of Hip

In brief

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 their recovery times post-surgery.

Key facts

Study ID

NCT06203691

Run by

Nirvana Water Sciences Corp

People needed

100

Starts

2024-02-21

Expected to finish

2024-08-30

Last updated by the study team

2024-03-27

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University Orthopedics Center — Altoona, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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