Calcium Fructoborate for Effect of Drugs

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Auburn University, Auburn, AL
Effect of Drugs
Calcium Fructoborate - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
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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

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

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: DietarySupplement
Placebo
DietarySupplement
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DietarySupplement

Trial 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
Photo of alabama 1Photo of alabama 2Photo of alabama 3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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