What side effects are associated with this type of intervention?

Common treatments for joint pain and inflammation, such as NSAIDs (ibuprofen and diclofenac), glucocorticoids, and dietary supplements (like EPO and Vitamin E), have various side effects. NSAIDs can cause gastrointestinal issues, including ulcers and bleeding, and may increase cardiovascular risks. Glucocorticoids, when used long-term, can lead to systemic effects like osteoporosis, weight gain, and increased infection risk. Dietary supplements like EPO and Vitamin E are generally well-tolerated but have not shown significant efficacy beyond placebo effects in trials.

What prior FDA approvals exist?

FDA-approved treatments for joint pain and inflammation include various NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) such as ibuprofen, naproxen, and celecoxib. These drugs are commonly used to manage symptoms of osteoarthritis and rheumatoid arthritis. Additionally, other treatments like corticosteroids and disease-modifying antirheumatic drugs (DMARDs) such as methotrexate are also approved for managing inflammatory conditions. While Calcium Fructoborate is being studied for its potential benefits, it is not yet FDA-approved, and more research is needed to establish its efficacy and safety.

What other types of research exist?

Promising novel alternatives to Calcium Fructoborate for anti-inflammatory and joint pain-relieving properties include caffeoylquinic acid (CA), curcuminoids, Boswellia, and recombinant human fibroblast growth factor 18 (rhFGF18). These alternatives have demonstrated potential in reducing inflammation and joint pain in various studies.

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Dietary Supplement

Calcium Fructoborate for Joint Discomfort

N/A

Recruiting

Research Sponsored by Auburn University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported or medically diagnosed knee joint pain for > 3 months (chronic)

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

Must not have

Participants medically diagnosed with rheumatoid arthritis

Any joint injury in the 6-months prior to the enrollment in the clinical trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the womac is administered at baseline, and at days 5, 14, 21, 28, 60, and 90.

Summary

This trial tests a natural supplement called calcium fructoborate (CFB) to see if it can reduce joint pain in adults. The supplement may help by reducing inflammation in the body. Participants will take the supplement daily for a few months to measure changes in their joint discomfort and overall well-being. Calcium fructoborate (CFB) is a dietary supplement used for managing joint discomfort, leveraging the benefits of organic boron-containing molecules.

Who is the study for?

This trial is for people aged 40-65 with knee osteoarthritis and chronic knee pain, who haven't taken antibiotics or joint discomfort drugs recently. Participants need basic computer skills, a smartphone, and reliable internet to join the virtual study but can't have certain health conditions like cardiovascular diseases or diabetes.

What is being tested?

The study tests if Calcium Fructoborate (CFB), a dietary supplement, can relieve joint discomfort over 90 days compared to a placebo. Participants will be randomly assigned to take either CFB or an inactive substance daily in this virtually conducted trial.

What are the potential side effects?

While not explicitly stated, potential side effects may include digestive issues since it's an oral supplement. However, as CFB is generally considered safe at recommended doses, significant side effects are not commonly expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had knee pain for more than 3 months.

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I haven't taken NSAIDs or pain relievers for 2 weeks and can avoid them during the study.

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I have been diagnosed with knee osteoarthritis.

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I am not currently taking any antibiotics.

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I am between 40 and 65 years old.

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I do not have any diagnosed psychiatric or neurological conditions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with rheumatoid arthritis.

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I have not had a joint injury in the last 6 months.

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I have a heart condition.

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I am either younger than 40 or older than 65 years old.

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I do not have knee osteoarthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the womac is administered at baseline, and at days 5, 14, 21, 28, 60, and 90.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the womac is administered at baseline, and at days 5, 14, 21, 28, 60, and 90.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the womac is administered at baseline, and at days 5, 14, 21, 28, 60, and 90. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

McGill Pain Questionnaire

WOMAC Assessment

Secondary study objectives

Daily Self-Reported Pain

Daily Self-Reported Sleep

Other study objectives

Compliance

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Calcium FructoborateActive Control1 Intervention

Calcium Fructoborate (CFB), is a proprietary, safe generally-recognized-as-safe (GRAS) supplement. The only content of the supplement is CFB - there are no excipients, binders, or flow agents, nor are there any other materials. 216mg of CFB will be administered daily for 90 days.

Group II: PlaceboPlacebo Group1 Intervention

The placebo will be a simple microcellulose, which is generally-recognized-as-safe (GRAS) and commonly used in food products.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for drug effects, particularly those with anti-inflammatory and joint pain-relieving properties, include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, corticosteroids, and supplements such as glucosamine sulfate. NSAIDs work by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which play a key role in the production of prostaglandins that cause inflammation and pain. Corticosteroids reduce inflammation by suppressing the immune system's response. Glucosamine sulfate is believed to support joint health by contributing to the synthesis of glycosaminoglycans, which are essential components of cartilage. These mechanisms are crucial for patients as they directly target the underlying processes causing pain and inflammation, thereby improving quality of life. Calcium Fructoborate, being studied for its anti-inflammatory and joint pain-relieving properties, may offer similar benefits by potentially modulating inflammatory pathways and supporting joint health.

Investigation into the duration of action of sustained-release ibuprofen in osteoarthritis and rheumatoid arthritis.Sulfate could mediate the therapeutic effect of glucosamine sulfate.