Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

Description

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.

Conditions

Arthropathy of Knee, Arthropathy of Hip

Study Overview

Study Details

Study overview

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.

Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

Condition
Arthropathy of Knee
Intervention / Treatment

-

Contacts and Locations

Altoona

University Orthopedics Center, Altoona, Pennsylvania, United States, 16602

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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).

Ages Eligible for Study

45 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Super Inspired LLC,

Candice St. Pierre, Ph.D., STUDY_CHAIR, Nirvana Water Sciences Corp

Study Record Dates

2024-08-30