Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 their recovery times post-surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: t
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• 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.

Locations
United States
Pennsylvania
University Orthopedics Center
RECRUITING
Altoona
Contact Information
Primary
Candice St. Pierre, Ph.D.
candice@feelsuper.pro
864-567-0362
Time Frame
Start Date: 2024-02-21
Estimated Completion Date: 2024-08-30
Participants
Target number of participants: 100
Treatments
Experimental: Supplement Group
50 of the 100 participants will be given supplements (Prepare \& Recover) for pre \& post operation.
Placebo_comparator: Non-Supplement Group
No supplements will be given to the non-supplement group.
Related Therapeutic Areas
Sponsors
Leads: Nirvana Water Sciences Corp

This content was sourced from clinicaltrials.gov