Examining the effects of calcium fructoborate on joint pain

Auburn University Joint Health Study

This study is testing whether a natural supplement called calcium fructoborate can help people aged 40-65 with chronic knee pain from osteoarthritis feel better over 90 days.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 40 Years to 65 Years
• Sex: All
• Sponsor: Auburn University (Academic / other)
• Locations: 1 site (Auburn, Alabama)
• Trial ID: NCT05438979 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of calcium fructoborate (CFB), a natural dietary supplement, on knee joint pain over a 90-day period. Participants aged 40-65 with chronic knee pain and a diagnosis of osteoarthritis will be randomized to receive either 216mg of CFB or a placebo daily. The study aims to assess changes in pain, discomfort, and quality of life using established pain assessment tools. Conducted virtually, it seeks to include over 300 participants to provide robust data on the supplement's efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-65 with chronic knee joint pain and a diagnosis of osteoarthritis.

Not a fit: Patients under 40 or over 65, or those with conditions like rheumatoid arthritis or diabetes, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective supplement for alleviating joint pain and improving quality of life for individuals with osteoarthritis.

How similar studies have performed: Previous studies have shown promising effects of calcium fructoborate, but this study aims to provide more definitive evidence with a larger sample size.

Eligibility criteria

Inclusion Criteria:

1. Between 40-65 years of age;
2. Self-reported or medically diagnosed knee joint pain for \> 3 months (chronic);
3. Diagnosis of osteoarthritis of the knee;
4. No diagnosed psychiatric or neurological condition;
5. Not taking antibiotics;
6. Not taking any other joint health supplement
7. Not taking prescription medications for OA or joint discomfort for the last 3 months
8. No 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 refrain from use of same throughout the study
9. Has reliable internet service;
10. Some computer literacy;
11. Has a smartphone; and
12. Has a laptop, desktop computer, or iPad.

Exclusion Criteria:

1. \<40 or \>65 years of age;
2. Does not have osteoarthritis of the knee;
3. Diabetes or other metabolic disorders;
4. Inflammatory and/or infectious health conditions;

6) Participants medically diagnosed with rheumatoid arthritis; 7) Participants with cardiovascular diseases; 8) Participants with liver and/or kidney problems; 9) Participants who are pregnant; 10) Health conditions that would prevent the participant from successfully completing the study (i.e., motor control conditions such as Parkinson's; psychiatric conditions such as ADHD); 11) Use of antibiotics 1 month prior to the enrollment in the study; 12) Physician prescribed use of pharmaceutical medications for OA or joint discomfort within 3 months prior to enrollment in this study; 13) Any joint injury in the 6-months prior to the enrollment in the clinical trial; 14) Unreliable or no internet access/service; 15) Unable to use a smartphone or lacking the computer literacy needed to complete the study 16) No laptop, desktop, or iPad that would allow for the completion of the study tasks.

Where this trial is running

Auburn, Alabama

• Auburn University — Auburn, Alabama, United States (Recruiting)

Study contacts

• Study coordinator: Jennifer L Robinson, Ph.D.

Conditions Effect of Drug; calcium fructoborate; virtual study; joint pain; knee pain; internet; joint health