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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will examine the effects of calcium fructoborate on joint discomfort. Participants will be given either the supplement or a placebo to take every day for 90 days.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

McGill Pain Questionnaire

WOMAC Assessment

Secondary outcome measures

Daily Self-Reported Pain

Daily Self-Reported Sleep

Other outcome measures

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 / 6Eligibility criteria met

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Who is running the clinical trial?

Auburn UniversityLead Sponsor

72 Previous Clinical Trials

14,105 Total Patients Enrolled

Media Library

Calcium Fructoborate (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05438979 — N/A

Drug Effects Research Study Groups: Calcium Fructoborate, Placebo

Drug Effects Clinical Trial 2023: Calcium Fructoborate Highlights & Side Effects. Trial Name: NCT05438979 — N/A

Calcium Fructoborate (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05438979 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cohort size of this research endeavor?

"Affirmative. According to the data published on clinicaltrials.gov, recruitment for this medical trial is still ongoing since its initial posting date of July 1st 2022 and last update in 19th of that same month. The research team behind it needs 300 individuals from a single site to participate."

Answered by AI

Is there an age restriction for enrolment in this research endeavor?

"This clinical trial has an age limit of 40-65 years old, as detailed in the enrollment criteria."

Answered by AI

Are there any vacancies available for enrolment in this clinical trial?

"Confirmed. Clinicaltrials.gov points to the fact that this medical trial, which was posted on July 1st of 2022, is presently seeking participants. Up to 300 patients are needed across a single recruitment site."

Answered by AI

Does my profile fit the criteria for participation in this research?

"This experiment is recruiting 300 participants of ages 40 to 65 and with the effects of drugs. To be considered, applicants must meet all the following criteria: No antibiotics for two weeks before enrollment; Abstain from NSAIDs or other analgesics during study duration; Chronic knee joint pain lasting longer than 3 months; WOMAC intake score between 42-52; McGill intake score between 50-65; Free from psychiatric or neurological conditions, Not taking any joint health supplements, Unmedicated OA/joint discomfort in past 3 months and access to reliable internet service."

Answered by AI

Recent research and studies

Biological Trace Element ResearchJournal

Calcium Fructoborate—potential Anti-inflammatory Agent

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.

Biological Trace Element ResearchJournal

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

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.

Biological Trace Element ResearchJournal

In Vitro Effects of Calcium Fructoborate Upon Production of Inflammatory Mediators by Lps-stimulated RAW 264.7 Macrophages

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 JournalJournal