RECRUITING

Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

Conditions

Arthropathy of Knee Arthropathy of Hip Arthroplasties Knee & Hip Replacement Dietary Supplements

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Nirvana Super Pro Supplementation in Orthopedic Surgery Patients

Quick Facts

Study Start:2024-02-21

Study Completion:2024-08-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06203691

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.

Ages Eligible for Study:45 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Study Contact

Candice St. Pierre, Ph.D.

CONTACT

864-567-0362

candice@feelsuper.pro

Principal Investigator

Candice St. Pierre, Ph.D.

STUDY_CHAIR

Nirvana Water Sciences Corp

Study Locations (Sites)

University Orthopedics Center

Altoona, Pennsylvania, 16602

United States

Collaborators and Investigators

Sponsor: Super Inspired LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-21

Study Completion Date2024-08-30

Study Record Updates

Study Start Date2024-02-21

Study Completion Date2024-08-30

Terms related to this study

Keywords Provided by Researchers

Arthroplasties
Knee & Hip Replacement
Dietary Supplements

Additional Relevant MeSH Terms

Arthropathy of Knee
Arthropathy of Hip