Protocol summary

Summary
The aim of this placebo controlled double blind randomized clinical trial will be to evaluate the effect of vitamin D3 supplementation on chronic osteomyelitis treatment and on sleep quality, anxiety and depression in patients with chronic osteomyelitis. Inclusion criterion is patients with chronic osteomyelitis ranged in age from 16 to 55 years old. The main exclusion criteria are concurrent other vitamin D supplements use during the study and use of immunosuppressants . A total of 50 patients will be recruited from clinic. These patients will be divided into two groups (intervention and placebo), each have 25 patients, using block randomization. After signing informed consent form by patients, vitamin D3 will be administered 200000 units at baseline and 100000 units after one, two, three, four and five months in intervention group and patients will take placebo with the same dose and frequency in placebo group. Depression, anxiety, and sleep quality will be evaluated using self-reported questionnaires at baseline, after 3 and 6 months. Clinical presentations, ESR, and CRP will be also evaluated at baseline and after 2 weeks, one, two, three, four, five and six months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201609026026N4
Registration date: 2017-04-10, 1396/01/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Fatemeh Dabaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5034
Email address
dabaghzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2016-09-28, 1395/07/07
Expected recruitment end date
2018-09-29, 1397/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of vitamin D3 supplementation on chronic osteomyelitis treatment and on sleep quality, anxiety and depression in patients with chronic osteomyelitis
Public title
Evaluating the effect of vitamin D3 supplementation on bone infection treatment and on sleep quality, anxiety and depression in patients with bone infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic osteomyelitis in the 16-55 age range Exclusion criteria: use of other vitamin D supplements; use of immunosuppressants; history of hypercalcemia or nephrolithiasis; sarcoidosis; kidney disorders requiring dialysis or polycystic kidney disease; cirrhosis; cancer; baseline plasma calcium (corrected for plasma albumin concentration) greater than 10.4 mg/dL or less than 8.4 mg/dL
Age
From 16 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Kerman University of Medical Sciences
Street address
Tahmasb abad Ave
City
Kerman
Postal code
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.KMU.REC.1395.786

Health conditions studied

1

Description of health condition studied
Chronic osteomyelitis
ICD-10 code
A49.0
ICD-10 code description
Staphylococcal infection, unspecified site

Primary outcomes

1

Description
ESR
Timepoint
At baseline, after 2 weeks and after 1, 2,3,4, 5 and 6 months
Method of measurement
Blood test

2

Description
CRP
Timepoint
At baseline, after 2 weeks and after 1, 2,3,4, 5 and 6 months
Method of measurement
Blood test

3

Description
Clinical presentations
Timepoint
At baseline, after 2 weeks and after 1, 2,3,4, 5 and 6 months
Method of measurement
Physical examination

Secondary outcomes

1

Description
Mental disorders
Timepoint
At baseline, after 3 and 6 months
Method of measurement
Questionnaires

Intervention groups

1

Description
Intervention: Four vitamin D3 pearls (50000 IU) at baseline and two vitamin D3 pearls (50000 IU) after 1, 2, 3, 4, and 5 months
Category
Treatment - Drugs

2

Description
Control: Four placebo pearls at baseline and two placebo pearls after 1, 2, 3, 4, and 5 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat clinic
Full name of responsible person
Fatemeh Dabaghzadeh
Street address
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman Univesity of Medical Sciences
Full name of responsible person
Miz. Hasani
Street address
Tahmasb abad Ave
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman Univesity 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
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Haft bagh high way
City
Kerman
Postal code
Phone
+98 34 3132 5212
Fax
Email
fatemeh_dabaghzadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciencers
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical pharmacist
Other areas of specialty/work
Street address
Haft bagh high way
City
Kerman
Postal code
Phone
+98 34 3132 5212
Fax
Email
fatemeh_dabaghzadeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Dabaghzadeh
Position
Clinical pharmacist
Other areas of specialty/work
Street address
Haft bagh high way
City
Kerman
Postal code
Phone
00
Fax
Email
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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