Protocol summary
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Study aim
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This study aimed to evaluate the effects of vitamin D supplementation on the menstrual patterns, sexual function, and sexual hormones among women with multiple sclerosis
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Design
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A parallel double-blind clinical trial
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Settings and conduct
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This double-blind clinical trial study was conducted in Dr. Nabavi Neurology Clinic in Tehran. Patients were randomly divided into intervention and control groups. In the intervention group, tablets containing vitamin D 2000 units were used twice a day for 12 weeks, and in the control group, a placebo containing paraffin was used. The patients were unaware of which group they were placed in, and the person who performed the statistical analysis was also unaware of the intervention and control groups.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria in this study were married women between the ages of 20 and 40 with multiple sclerosis who had the same treatment regimen and whose vitamin D level was less than 50. If the patients did not want to continue the study or did not take more than one dose of vitamin D, they were excluded from the study.If the patients are in the acute stage of the disease or have comorbidity diseases, they will not be included in the study.
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Intervention groups
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Participants in the intervention group were given vitamin D (2000 IU, Zahravi Pharmaceutical Co) tablets and were asked to take two daily tablets for twelve consecutive weeks. And in the control group, a placebo containing edible paraffin was used.
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Main outcome variables
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menstrual pattern, sexual function, and sexual hormones
General information
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Reason for update
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Due to making and correcting minor changes in the inclusion criteria, study sampling time, and blinding of this research. Also, due to the non-cooperation of the hospitals for sampling, Dr. Nabavi's specialized Neurology clinic was used for sampling.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016061528449N4
Registration date:
2016-08-29, 1395/06/08
Registration timing:
prospective
Last update:
2023-01-13, 1401/10/23
Update count:
1
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Registration date
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2016-08-29, 1395/06/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Iran University of Medical Sciences
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Expected recruitment start date
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2016-08-22, 1395/06/01
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Expected recruitment end date
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2016-11-20, 1395/08/30
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Actual recruitment start date
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2017-08-01, 1396/05/10
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Actual recruitment end date
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2018-02-01, 1396/11/12
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Trial completion date
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2018-02-19, 1396/11/30
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Scientific title
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Clinical trial to evaluate the effect of vitamin D supplements on menstrual pattern, levels of Sexual hormones and sexual function in women with multiple sclerosis
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Public title
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Effect of vitamin D pills on Menstrual pattern, levels of Sexual hormones and Sexual function in women with Multiple sclerosis
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Married women between 20 and 40 years of age;
Confirmation on diagnosis with MS by neurologist during the past year and Having the same therapeutic regimen
No acute or chronic disease other than multiple sclerosis
No record of disease associated with vitamin D malabsorption (constipation, diarrhea, celiac sprue, short bowel syndrome, and cystic fibrosis)
No suffering the husband of chronic diseases and mental illness
A minimum of one sexual intercourse in a month
The vitamin D serum level of lower than 50 (ng/mL)
No record of vitamin D supplementations There is no special diet and be omnivorous
The expanded disability status score of lower than 4
no exposure to the severe crisis since the death of someone close to 3 months
Not using hormonal contraception at least in the last 3 months; No pregnancy and lactation and does not plan to become pregnant in the last 3 months
Exclusion criteria:
reluctant to continue the study
Aggravation of the disease during the study
Accurring of pregnancy during the study
Facing a critical factor causing such death of a family member or hospitalization in the last 3 months
No using regular consumption of vitamin D and avoiding the use of more than one dose during the study;
Appearing serious complications that require neurological intervention
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Age
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From 20 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
68
Actual sample size reached:
62
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible Participants were consecutively recruited and randomly allocated to an intervention and a control group. For randomization, a table of random numbers from 1 to 200 was generated and then, each new patient recruited to the study was asked to randomly select a number between 1 and 200. She would be allocated to the intervention group if she selected a three-digit odd number, while she would be allocated to the control group if she selected a two-digit even number. Then, selected numbers were removed from the table. If the patient selected any other numbers, she would be asked to select another number until she can pick out either a three-digit odd number or a two-digit even number
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This was a double-blind study in which neither participants nor statistical analyst was aware of the group allocation. For blinding, participants were not provided with information about the packet content of the tablets. Moreover, they were visited individually and were unaware of the tablets provided to other participants. Vitamin D and placebo tablets used in this study were produced by Zahravi Pharmaceutical Company, Tabriz, Iran. Placebo tablets contain edible paraffin.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-05-28, 1395/03/08
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Ethics committee reference number
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IR.IUMS.REC. 1395.9311373017
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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Serum levels of 25 hydroxy vitamin D3
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Timepoint
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The patients' serum 25 hydroxy vitamin D3 levels measured twice ( once before and once after the last day of the intervention)
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Method of measurement
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Blood sampling
2
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Description
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Levels of Sexual hormones
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Timepoint
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Patients are tested twice for Levels of Sexualhormones(Estrogen andTestosterone)(One day before the first day of training–one day after the final day training course).
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Method of measurement
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Blood sampling
Secondary outcomes
1
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Description
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Menstrual pattern
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Timepoint
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Patients are tested twice for Menstrual pattern. (One day before the first day of training–one day after the final day training course).
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Method of measurement
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Questionnaire
2
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Description
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Sexual function
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Timepoint
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Patients are tested twice for Sexual function . (One day before the first day of training–one day after the final day training course).
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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In the intervention group using transparent pills of 25 hydroxy vitamin D 3
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Category
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Placebo
2
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Description
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In the control group using placebo
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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If there is a need to conduct secondary studies or other researchers need the data, the data file, which has been anonymized and includes all the variables measured in this research, will be provided.
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When the data will become available and for how long
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One year after the results are published
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To whom data/document is available
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Data for all academic researchers or industrial research centers
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Under which criteria data/document could be used
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If there is a need to do additional studies or secondary studies
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From where data/document is obtainable
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If you need to receive data, contact Ms. Zarabadipour :00989127837998
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What processes are involved for a request to access data/document
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Provide the reason for the request and the person or institution that needs this data
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Comments
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