Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-01 @ 6:13 AM
Study NCT ID:
NCT01709968
Status:
TERMINATED
Last Update Posted:
2017-07-21
First Post:
2012-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnesium Oxide Monohydrate for Nocturnal Leg Cramps
Sponsor:
Uzi Milman
Organization:
Study Overview
Official Title:
Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MgNLC
Brief Summary:
Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential benefits in trials of magnesium. This is a single center, prospective, randomized, double blind, placebo controlled clinical trial that aims to investigate the effect of treatment with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide \& Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce the number and severity of NLC; an improvement in the quality of life and quality of sleep may ensue.
Detailed Description:
Ads in the local media and pharmacies will invite individuals afflicted by NLC to participate in the study. Each participating individual will undergo two weeks of eligibility screening followed by 4-week double-blind treatment. The number, severity and duration of NLC will be measured daily as documented in a designated, structured sleep dairy. Quality of life and quality of sleep will be assessed by SF-36 and PSQI questionnaires, respectively, to be completed twice - at enrollment and within one week of the end of the treatment period.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: