NCT03807219

Brief Summary

A randomized, multicenter, prospective, double-blind, placebo-controlled, clinical trial in the parallel groups to determine the efficacy and safety of a 60-day use of the dietary supplement Magnox Comfort compared to the placebo in subjects with nocturnal legs cramps

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

January 9, 2019

Last Update Submit

January 12, 2019

Conditions

Nocturnal Leg Cramps

Keywords

nocturnal legs crampslegs crampsNLC

Outcome Measures

Primary Outcomes (1)

  • The number of episodes of NLC

    The study subject will record the number of episodes of nocturnal legs cramps in the study subject's diary

    The difference in count of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.

Secondary Outcomes (5)

  • Duration of NLC

    The difference in duration of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.

  • Severity of pain associated with NLC

    The difference in severity of pain of nocturnal legs cramps documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.

  • Change in quality of life (SF-36)

    The difference in quality of life documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.

  • Changing in the sleep quality

    The difference in sleep quality documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.

  • Drop-out rate

    The difference in drop-out rate documented in the trial, as compared between the study product and the placebo treated individuals, during a treatment period of 60-day.

Study Arms (2)

Magnox Comfort

ACTIVE COMPARATOR

80 subjects will be on the Magnox Comfort arm.

Dietary Supplement: Magnox Comfort

Placebo

PLACEBO COMPARATOR

80 subjects will be on the Placebo arm.

Other: Placebo

Interventions

Magnox ComfortDIETARY_SUPPLEMENT

Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).

Magnox Comfort
PlaceboOTHER

placebo

Placebo

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study subject is informed and he/she was given enough time to think on his participation in the study and signed the informed consent form before the beginning of any procedures;
  • A study subject is a man or a woman over the age of 45 years;
  • The study subject has an established diagnosis of the nocturnal legs cramps;
  • The study subject understands the Ukrainian language;
  • The study subject has satisfactory results of the neurological examination of both lower extremities;
  • The study subject has a telephone and can use it permanently;

You may not qualify if:

  • The study subject has less than 4 episodes of NLC during the 14-day screening period;
  • There is necessity for significant change in the treatment tactics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Kharkiv City Clinic №9

Kharkiv, Kharkivs’ka Oblast’, Ukraine

Location

Kyiv city clinic №9

Kyiv, Kyiv Oblast, Ukraine

Location

Medical Center "Artem"

Kyiv, Kyiv Oblast, Ukraine

Location

Medical Center "Preventclinic" LLC

Kyiv, Kyiv Oblast, Ukraine

Location

City clinic №5

Lviv, Lviv Oblast, Ukraine

Location

Odesa Railway City Clinic

Odesa, Odesa Oblast, Ukraine

Location

Medical center "Desna" LLC

Ternopil, Ternopil Oblast, Ukraine

Location

Related Publications (1)

  • Barna O, Lohoida P, Holovchenko Y, Bazylevych A, Velychko V, Hovbakh I, Bula L, Shechter M. A randomized, double-blind, placebo-controlled, multicenter study assessing the efficacy of magnesium oxide monohydrate in the treatment of nocturnal leg cramps. Nutr J. 2021 Oct 31;20(1):90. doi: 10.1186/s12937-021-00747-9.

    PMID: 34719399DERIVED

MeSH Terms

Conditions

Sleep-Wake Transition Disorders

Condition Hierarchy (Ancestors)

ParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Nitsan Primor

    Naveh Pharma LTD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 16, 2019

Study Start

February 9, 2018

Primary Completion

August 27, 2018

Study Completion

August 27, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

UA(7)