Protocol summary

Summary
Objective of study: Assessing the effect of vitamin D supplement on the score and quality of sleep in 20 to 50 year-old people with sleep disorders. Design of the study: This is a randomized, double-blinded, placebo-intervention trial. Conduct: This study will be conducted in Golestan Hospital, Ahwaz. The eligible subjects will be chosen by convenience sampling and randomly will be categorized into two intervention and control groups, each including 45 people. Subjects: Ninety people, all from 20 to 50 years old and with sleep disorder, who score 5 or higher based on Pittsburgh Sleep Quality Index. Intervention: After completing basic information and filling in Pittsburgh sleep quality questionnaire, intervention group will receive vitamin D tablets (50000 units), one tablet every fortnight, for 2 months; meanwhile, control group will receive Placebo. Inclusion criteria: Personal willingness to participation; Aging 20 to 50 year old; Suffering sleep disorder based on Pittsburgh Sleep Quality Index; No allergy to vitamin D supplement; No mental psychic disorder; No consumption of sleep medication or anti-depression; No consumption of vitamin D supplement three months before intervention. Exclusion criteria: Allergy to vitamin D supplement; Consumption of sedative drugs; Suffering mental problems such as hyper-depression or excessive anxiety; Pregnancy or lactation; Drinking or smoking; Lack of willingness to participation. Main outcome variables: Subjects' sleep quality will be evaluated by Pittsburgh sleep quality questionnaire before intervention and 2 months after it. Secondary outcome variables: Serum vitamin D level will be evaluated before intervention and 2 months after it.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015122725723N1
Registration date: 2016-02-14, 1394/11/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-14, 1394/11/25
Registrant information
Name
MOHAMMAD ABOLFATHI
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3336 1984
Email address
abolfathi.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-02-06, 1394/11/17
Expected recruitment end date
2016-05-06, 1395/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplement on the score and quality of sleep in 20 to 50 year-old people with sleep disorders compared with control group
Public title
The effect of vitamin D supplement on the score and quality of sleep in 20 to 50 year-old people with sleep disorders compared with control group
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Personal willingness to participation; Aging 20 to 50 year old; Suffering sleep disorder based on Pittsburgh Sleep Quality Index; No allergy to vitamin D supplement; No mental psychic disorder; No consumption of sleep medication or anti-depression; No consumption of vitamin D supplement three months before intervention. Exclusion criteria: Allergy to vitamin D supplement; Consumption of sedative drugs; Suffering mental problems such as hyper-depression or excessive anxiety; Pregnancy or lactation; Drinking or smoking; Lack of willingness to participation.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Hwy, Ahvaz, Khuzestan
City
Ahvaz
Postal code
61357-15794
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.AGUMF.REC.1394.514

Health conditions studied

1

Description of health condition studied
Sleep disorders
ICD-10 code
F51.8
ICD-10 code description
Other nonorganic sleep disorders

Primary outcomes

1

Description
Sleep quality
Timepoint
Before intervention and 2 months afther intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

1

Description
25 Hydroxy Vitamin D3 Serum
Timepoint
Before intervention and 2 months after intervention
Method of measurement
ELISA

Intervention groups

1

Description
The control group will receive one Placebo tablet every fortnight for 2 months. These tablets contain edible paraffin oil.
Category
Placebo

2

Description
The intervention group Will receive 50000 units of vitamin D tablets, one tablet every fortnight for 2 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Abolfathi Mohammad
Street address
Golestan Hwy, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Saky Nader
Street address
Golestan Hwy, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hosseini Seyed Ahmad
Position
phd in biochemistery
Other areas of specialty/work
Street address
Golestan Hwy, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 1336 7544
Fax
Email
seyedahmadhosseini@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Shahi Majed
Position
phd in nutrition
Other areas of specialty/work
Street address
Golestan Hwy, Ahvaz
City
Ahvaz
Postal code
61357-15794
Phone
+98 61 3161
Fax
Email
shahi334@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Abolfathi Mohammad
Position
Msc student of Nutrition sciences
Other areas of specialty/work
Street address
Golestan Hwy, Ahvaz
City
Ahvaz
Postal code
Phone
Fax
Email
abolfathi.m54@gmail.com
Web page address

Sharing plan

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