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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: Completed NA study of Tendon Injuries and Tendon Rupture, sponsored by University of California, Davis.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Knee laxity will be measured at months 4 and 5 after the 3-month intervention period of the study. The measurement will be made in millimeters using a specially designed GNRB arthrometer, which is a computerized and automatic medical device developed and validated by Genourob.
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 |
What the finished NCT03747198 record still lists
NCT03747198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03747198's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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