Effect of Oral Magnesium Therapy for Periodic Limb Movements in Sleep
Design
A randomised, blinded, placebo controlled clinical trial with a parallel group design of 14 patients in each group (total number of 28), randomized with Random numbers table
Settings and conduct
patients underwent polysomnography with periodic limb movements in sleep will enroll in the study and divide randomly in two groups, after evaluation of exclusion criteria and Informed consent. In the first group a 250 mg magnesium tablet will prescribe for 4 weeks. The second group will receive placebo. Patients will be blind to drugs. Then they will reassess with polysomnography for periodic limb movements in sleep and will be compared to pretreatment.
Participants/Inclusion and exclusion criteria
Enclusion criteria:
periodic limb movements in polysomnography
Exclusion criteria:
decrease in ferritin level
increase in blood urea nitrogen
increase in cratinine
pregnancy
iron deficiency anemia
Intervention groups
Prescribing Oral Magnesium and Placebo
Main outcome variables
number of periodic limb movements in sleep
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170128032249N2
Registration date:2019-06-16, 1398/03/26
Registration timing:prospective
Last update:2019-06-16, 1398/03/26
Update count:0
Registration date
2019-06-16, 1398/03/26
Registrant information
Name
Zahra Banafsheh Alemohammad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5567 7333
Email address
alemohammadz@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Oral Magnesium Therapy for Periodic Limb Movement Syndrome: a Randomized Clinical Trial
Public title
Oral Magnesium Therapy in Periodic Limb Movement Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
periodic limb movements in polysomnography
Exclusion criteria:
decrease in ferritin level
increase in blood urea nitrogen
increase in cratinine
pregnancy
iron deficiency anemia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization by Random Numbers Table
Blinding (investigator's opinion)
Single blinded
Blinding description
Blindness of Participants Regarding Main Drug or Placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.TUMS.VCR.REC.1397.178
Health conditions studied
1
Description of health condition studied
periodic limb movements in sleep
ICD-10 code
G47.61
ICD-10 code description
Periodic limb movement disorder
Primary outcomes
1
Description
periodic limb movements in sleep
Timepoint
At the beginning of the study and 28 days after the start of oral magnesium
Method of measurement
polysomnography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a 250 mg magnesium tablet will prescribe once a day for 4 weeks after a meal
Category
Treatment - Drugs
2
Description
Control group: a placebo tablet will prescribe once a day for 4 weeks after a meal
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sleep Clinic of Baharloo Hospital
Full name of responsible person
Zahra Banafsheh Alemohammad
Street address
Baharloo Hospital, Behdari St., Rahahan Sq.
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5567 7333
Email
hosp-baharloo@tums.ac.ir
Web page address
http://baharloohospital.tums.ac.ir/baharloo/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
sixth floor, Tehran University of Medical Sciences, Ghods Ave., Keshavarz blvd.,
City
Tehran
Province
Tehran
Postal code
1424456666
Phone
+98 21 8163 3698
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Banafsheh Alemohammad
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Occupational Medicine
Street address
Baharloo Hospital, Behdari St., Rahahan Sq.
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5567 7333
Fax
+98 21 5564 8189
Email
alemohammadz@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Banafsheh Alemohammad
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Occupational Medicine
Street address
Baharloo Hospital, Behdari St., Rahahan Sq.
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5567 7333
Fax
+98 21 5564 8189
Email
alemohammadz@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Banafsheh Alemohammad
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Occupational Medicine
Street address
Baharloo Hospital, Behdari St., Rahahan Sq.
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5567 7333
Fax
+98 21 5564 8189
Email
alemohammadz@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available