Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
Natural dietary health supplements that may improve quality of life by relieving joint discomfort have been of increasing interest. Recent studies have demonstrated promising effects of one such supplement - calcium fructoborate (CFB). Preliminary evidence suggests that CFB may reduce joint discomfort, however, few well-powered studies have been conducted to assess the true effects of this supplement. In this study, conducted virtually, we will examine changes in joint discomfort over a 90 day period. Participants will be randomized to receive either 216mg CFB or placebo (i.e., 216mg microcellulose) to take every day for the study period.
Treatment Effectiveness
Effectiveness Progress
Other trials for Effect of Drugs
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: The WOMAC is administered at baseline, and at days 5, 14, 21, 28, 60, and 90.
Day 90
Compliance
Day 5
McGill Pain Questionnaire
Day 5
WOMAC Assessment
Day 90
Daily Self-Reported Pain
Day 90
Daily Self-Reported Sleep
Trial Safety
Safety Progress
Other trials for Effect of Drugs
Trial Design
2 Treatment Groups
Calcium Fructoborate
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group
300 Total Participants · 2 Treatment Groups
Primary Treatment: Calcium Fructoborate · Has Placebo Group · N/A
Calcium Fructoborate
DietarySupplement
ActiveComparator Group · 1 Intervention: Calcium Fructoborate · Intervention Types: DietarySupplementPlacebo
DietarySupplement
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DietarySupplementTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: the womac is administered at baseline, and at days 5, 14, 21, 28, 60, and 90.
Closest Location: Auburn University · Auburn, AL
2015First Recorded Clinical Trial
2 TrialsResearching Effect of Drugs
15 CompletedClinical Trials
Who is running the clinical trial?
Auburn UniversityLead Sponsor
48 Previous Clinical Trials
13,047 Total Patients Enrolled
1 Trials studying Effect of Drugs
200 Patients Enrolled for Effect of Drugs
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have not taken antibiotics for at least 4 weeks.
You are willing to make best efforts to refrain from use of NSAIDS or other pain relievers for two (2) weeks prior to enrollment in the study and who are willing to make best efforts to continue use of same throughout the study.
You are between 40 and 65 years of age.\n
You have knee joint pain for 3 months or more.
You have no diagnosed psychiatric or neurological condition.
You are taking prescription medications for OA or joint discomfort for the last 3 months.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Scorei, Romulus Ion, and Petre Rotaru. 2011. “Calcium Fructoborate—potential Anti-inflammatory Agent”. Biological Trace Element Research. Springer Science and Business Media LLC. doi:10.1007/s12011-011-8972-6.
- Scorei, Romulus, Paul Mitrut, Iulian Petrisor, and Iulia Scorei. 2011. “A Double-blind, Placebo-controlled Pilot Study to Evaluate the Effect of Calcium Fructoborate on Systemic Inflammation and Dyslipidemia Markers for Middle-aged People with Primary Osteoarthritis”. Biological Trace Element Research. Springer Science and Business Media LLC. doi:10.1007/s12011-011-9083-0.
- Scorei, Romulus Ion, Cristina Ciofrangeanu, Raluca Ion, Anisoara Cimpean, Bianca Galateanu, Valentina Mitran, and Dana Iordachescu. 2009. “In Vitro Effects of Calcium Fructoborate Upon Production of Inflammatory Mediators by Lps-stimulated RAW 264.7 Macrophages”. Biological Trace Element Research. Springer Science and Business Media LLC. doi:10.1007/s12011-009-8488-5.
- EFSA Panel on Nutrition, Novel, Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, John Kearney, Alexandre Maciuk, et al.. 2021. “Safety of Calcium Fructoborate as a Novel Food Pursuant to Regulation (EU) 2015/2283”. JB. EFSA Journal 19 (7). IT. doi:10.2903/j.efsa.2021.6661.
- Scorei, Iulia Daria, and Romulus Ion Scorei. 2013. “Calcium Fructoborate Helps Control Inflammation Associated with Diminished Bone Health”. Biological Trace Element Research. Springer Science and Business Media LLC. doi:10.1007/s12011-013-9800-y.
- Mogoşanu, George Dan, Andrei Biţă, Ludovic Everard Bejenaru, Cornelia Bejenaru, Octavian Croitoru, Gabriela Rău, Otilia-Constantina Rogoveanu, et al.. 2015. “Calcium Fructoborate for Bone and Cardiovascular Health”. Biological Trace Element Research. Springer Science and Business Media LLC. doi:10.1007/s12011-015-0590-2.
- Reyes-Izquierdo, Tania, Ruby Argumedo, Michael Phelan, Robert Keller, Cynthia Shu, and Zibigniew Pietrzkowski. 2014. “Short-term Efficacy of Calcium Fructoborate on Subjects with Knee Discomfort: A Comparative, Double-blind, Placebo-controlled Clinical Study”. Clinical Interventions in Aging. Informa UK Limited. doi:10.2147/cia.s64590.
- Price, A. K., M. R. C. de Godoy, T. A. Harper, K. E. Knap, S. Joslyn, Z. Pietrzkowski, B. K. Cross, K. B. Detweiler, and K. S. Swanson. 2017. “Effects of Dietary Calcium Fructoborate Supplementation on Joint Comfort and Flexibility and Serum Inflammatory Markers in Dogs with Osteoarthritis1,2”. Journal of Animal Science. Oxford University Press (OUP). doi:10.2527/jas.2017.1588.
- Dworkin, Robert H., Dennis C. Turk, Dennis A. Revicki, Gale Harding, Karin S. Coyne, Sarah Peirce-Sandner, Dileep Bhagwat, et al.. 2009. “Development and Initial Validation of an Expanded and Revised Version of the Short-form Mcgill Pain Questionnaire (SF-MPQ-2)”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.pain.2009.02.007.
- Thomsen, Morten G, Roshan Latifi, Thomas Kallemose, Kristoffer W Barfod, Henrik Husted, and Anders Troelsen. 2016. “Good Validity and Reliability of the Forgotten Joint Score in Evaluating the Outcome of Total Knee Arthroplasty”. Acta Orthopaedica. Informa UK Limited. doi:10.3109/17453674.2016.1156934.
- Scorei, R., V. M. Cimpoiasu, and Dana Iordachescu. 2005. “In Vitro Evaluation of the Antioxidant Activity of Calcium Fructoborate”. Biological Trace Element Research. Springer Science and Business Media LLC. doi:10.1385/bter:107:2:127.
- Melzack, Ronald. 1975. “The Mcgill Pain Questionnaire: Major Properties and Scoring Methods”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/0304-3959(75)90044-5.
- Jennifer L. Robinson, Ph.D. 2022. "Joint Health Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05438979.
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