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Effect of vitamin D on menstrual pain in women of childbearing age in comparison with placebo; double-blind randomized controlled clinical trial

Protocol summary

Summary
Primary menstrual pain is one of the most common menstrual disorders. It usually starts 6-12 months after first menstruation cycle. Fifty percentages of women of childbearing age suffer it and about 50% of people worldwide suffer from vitamin D deficiency too. Studies have shown that Vitamin D may reduce the symptoms of premenstrual syndrome, particularly pain. Based on our knowledge, 2 studies have examined the effect of vitamin D on menstrual cramps. The aim of this study was to investigate the effect of vitamin D supplementation on the menstrual pain in women of childbearing age. This study will be conducted as a randomized, double-blind clinical trial. Sixty women, 18 to 30 years old with Primary menstrual pain and 25 hydroxycholecalciferol ≤30ngm/ml are investigated in two intervention and control groups. Serum 25(OH) D3, magnesium, calcium, phosphorus, alkaline phosphates, and pain severity are measured in all participants. Intervention group is given cholecalciferol and the control group given placebo weekly for 2 months. The changes in laboratory tests, non-steroidal anti inflammatory drugs consumption, and pain change severity will be compared 2 months after cholecalsiferol administration in tow groups. One month after discontinuation of the drug, the pain severity is measured and compared to the pain 2 months after treatment and baseline.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012100110980N1
Registration date: 2012-10-18, 1391/07/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-10-18, 1391/07/27
Registrant information
Name
Nooshin Shirzad
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
nshirzad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on menstrual pain in women of childbearing age in comparison with placebo; double-blind randomized controlled clinical trial
Public title
The effect of vitamin D on primary menstrual pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Women aged 18-30 y; with normal menstrual cycles (cycles lasted 21 to 35, with menstrual lasting 3 to 7 days); at least 4 consecutive painful periods in the past 6 months with a diagnosis of primary dysmenorrhea; Serum 25-hydroxyvitamin D level ≤ 30 ng/dl. Exclusion criteria: Secondary menstrual pain diagnosed by ultrasound examination; Previous and current use of intrauterine contraceptive devices within the 6 months prior; Previous and current use of drugs including calcium or vitamin D within the 6 months prior; Recent use of oral contraception drugs during the past 2 months; Smoking; BMI ≥ 30; history of kidney stones; granulomatous disease; hyperparathyroidism and any malignant disease.
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, Deputy of Research
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2013-01-21, 1391/11/02
Ethics committee reference number
91-04-39-19158-77016

Health conditions studied

1

Description of health condition studied
primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
primary dysmenorrhoea

Primary outcomes

1

Description
Menstrual pain severity
Timepoint
before treatment, 2 months after the treatment, 1 month after finishing intervention
Method of measurement
Visual pain scale

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: cholecalciferol 50,000 IU oral tablets, once a week for 8 weeks.
Category
Treatment - Drugs

2

Description
control group: placebo, oral tablet, once a week for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Shahrzad Jafari-Adli
Street address
Arash Women 's Hospital, Rashid Ave., Resalat Highway, Tehranpars
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Deputy of Research
Full name of responsible person
Dr Akbar Fotouhi
Street address
Ghods St., Keshavarz Blvd. Vali-e-Asr Ave.
City
Tehran
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, Deputy of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Shahrzad Jafari-Adli
Position
general practitioner
Other areas of specialty/work
Street address
Research development Center, Arash women's hospital, Shahid Bagheri highway, Resalat highway
City
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
shahrzad_jafari@hotmail.com ; sh-jafariadli@farabi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences (TUMS)
Full name of responsible person
Nooshin Shirzad
Position
subspecialty in Endocrinology and Metabolism
Other areas of specialty/work
Street address
Arash women's hospital., Shahid Bagheri highway, Resalat highway
City
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
nshirzad@tumas.ac.ir ; nshirzad11@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahrzad Jafari-Adli
Position
General Practitioner
Other areas of specialty/work
Street address
Research development Center, Arash women's hospital, Shahid Bagheri highway, Resalat highway
City
Tehran
Postal code
1653915981
Phone
+98 21 7771 9922
Fax
+98 21 7788 3196
Email
shahrzad_jafari@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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