Protocol summary

Summary
In this study, 200 female nurses working in Shahid Beheshti Hospital with at least one year of experience will be considered during 2014. Subjects with chronic disease, bone fracture and vitamin D supplementation in the past 6 months are excluded. They complete the questionnaires of fatigue and muscle pain and 3 cc of blood is taken from them to measure the levels of vitamin D. Then 50,000 IU of vitamin D will be prescribed weekly for the nurses have blood levels of vitamin D less than 30 ng per mL After 10 weeks, blood levels of vitamin D, fatigue and muscle pain will be measured again. Blood levels of vitamin D, fatigue and muscle pain, before and after the intervention will be compared with each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041517298N1
Registration date: 2014-06-22, 1393/04/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-22, 1393/04/01
Registrant information
Name
Mahla Madani
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 9076
Email address
madani.mahla@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D on fatigue and musculo-skeletal pain of female nurses
Public title
Effect of vitamin D on fatigu and musculo-skeletal pain of female nurses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female nurses working in Shahid Beheshti Hospital; At least one year of experience in hospital Exclusion criteria: Chronic Diseases; Anemia; Diabetes; Thyroid, parathyroid and coronary heart diseases; Depression; Cancer; Musculoskeletal diseases; Bone fracture and musculoskeletal trauma in the past 6 months; Fracture during the study; Vitamin D supplementation in the past 6 months
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Approval date
2014-02-23, 1392/12/04
Ethics committee reference number
29/5/1/4817/پ

Health conditions studied

1

Description of health condition studied
Fatigue
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue

2

Description of health condition studied
Musculo-skeletal pain
ICD-10 code
M79.1
ICD-10 code description
Myalgia

Primary outcomes

1

Description
Fatigue
Timepoint
Before and after intervention
Method of measurement
Fatigue scale

2

Description
Musculo-skeletal pain
Timepoint
Before and after intervention
Method of measurement
Nordic questionary

3

Description
Vitamin D level
Timepoint
Before and after intervention
Method of measurement
Blood sample

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Oral vitamin D, 50000 IU weekly for 10 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr.Mohammad Reza Sharif
Street address
Shahid Beheshti Hospital, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Mahla Madani
Position
MA Nursing
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
+98 31 5554 8900
Email
madani.mahla@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahla Madani
Position
MA Nursing
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
madani.mahla@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahla Madani
Position
MA Nursing
Other areas of specialty/work
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
madani.mahla@yahoo.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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