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NCT03747198 · ClinicalTrials.gov registry record · NA
Methylsulfonylmethane on Knee Laxity
A NA study of Tendon Injuries and Tendon Rupture, sponsored by University of California, Davis.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT03747198 is a NA study of Tendon Injuries and Tendon Rupture that has completed, run by University of California, Davis. The registered enrollment target is 32 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03747198, a NA study of Tendon Injuries and Tendon Rupture, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed research will focus on determining the effect of methylsulfonylmethane (MSM) on knee laxity changes through the menstrual cycle in young active females. As an extension to recent discovery, that MSM reverses the negative effect of estrogen on engineered ligament function, the proposed work is designed to determine whether MSM can decrease the negative effect of estrogen on knee laxity in females. Ligament function is determined by the content and cross-linking of collagen, which is influenced by a milieu of biochemical and mechanical parameters. The greater the amount and cross-linking the greater the stiffness and strength of these connective tissues. In engineered ligaments it has been previously shown that the high levels of estrogen, normally present in the days before and after ovulation, can inhibit the cross-linking enzyme lysyl oxidase. This decrease in collagen cross-linking likely increases connective tissue laxity and contributes to observed 4-fold greater occurrence of anterior cruciate ligament (ACL) rupture in females. Conversely, MSM increases collagen cross-linking and recent work conducted by the Baar lab in engineered human ligaments treated with high estrogen demonstrated that MSM could completely reverse the effects of estrogen on ligament mechanics. The proposed research aims to advance this promising pre-clinical data and apply in a clinical trial. This research also proposes to quantify that knee laxity increases up to 5mm between the first day of menstruation and the day after ovulation and also that the magnitude of the increase in laxity is directly related to the magnitude of the change in estrogen. Importantly, a direct relationship between knee laxity and ACL rupture exists. For every 1.3mm increase in anterior-posterior knee displacement, the odds of ACL rupture increase 4-fold. Therefore, any treatment that decreases knee laxity could be expected to reduce ACL ruptures and have widespread application across the general
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT methylsulfonylmethane
Study Locations (1)
California
- Neurobiology, Physiology & Behaviour - Davis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2019-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03747198
The ClinicalTrials.gov registry entry for NCT03747198 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Tendon Injuries appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03747198 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03747198 about?
NCT03747198 is a clinical study titled "Methylsulfonylmethane on Knee Laxity". The proposed research will focus on determining the effect of methylsulfonylmethane (MSM) on knee laxity changes through the menstrual cycle in young active females. As an extension to recent discovery, that MSM reverses the negative effect of estrogen on engineered ligament function, the proposed ...
What is the current status of trial NCT03747198?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2019-02-01. Estimated completion is 2019-10-01.
What conditions does trial NCT03747198 study?
This clinical trial studies the following conditions: Tendon Injuries, Tendon Rupture, Ligament Injury, Ligament; Laxity.
What interventions are being tested in trial NCT03747198?
The interventions under investigation include: Placebo (OTHER), methylsulfonylmethane (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03747198?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03747198 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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