Protocol summary

Summary
Objectives: The purpose of this study is to evaluate the effect of vitamin D3 and calcium supplementation on levels of sex hormone cortisol and inflammatory biomarkers Interleukin 10, high-sensitivity C-reactive protein (hsCRP), in women with postpartum depression. Design: This study is a randomized, double-blind controlled randomized trial with 8 weeks period. Setting and conduct: Eighty one patients with postpartum depression and serum vitamin D levels less than normal range, with consecutive sampling method, will be selected from the Health Center number 1, located in the west of the Ahvaz city. Edinburgh questionnaire will be used to evaluate clinical symptoms. In addition, the severity of anxiety will be examined by the Spielberger Questionnaire. Questionnaires at baseline and every 2 weeks for 8 weeks will be completed by the patients. Major Inclusion criteria: Score of 12 and above from Edinburgh questionnaire; a period range from 1 month until 6 months after child birth. Major Exclusion criteria: Vitamin D and calcium levels to normal or above normal range; chronic diseases. Intervention: The subjects will be divided into 3 groups based on randomized block design: group 1 will receive 50000 units vitamin D3, every 14 days and one calcium carbonate tablet (500 milligram, daily), group 2 will receive 50000 units vitamin D3, every 14 days and one calcium placebo (500 milligram, daily), group 3 (control group) will receive vitamin D3 placebo contains edible paraffin, every 14 days and calcium placebo (daily), for 8 week. Main outcome variables: Biochemical measurements include serum levels of inflammatory factors (Interleukin 10, hsCRP) and cortisol will be measured using ELISA assay.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016111016123N12
Registration date: 2017-09-28, 1396/07/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-28, 1396/07/06
Registrant information
Name
Sima Jafarirad
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8317
Email address
jafarirad-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-08-28, 1396/06/06
Expected recruitment end date
2017-09-28, 1396/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D and calcium supplementation on serum levels of cortisol and inflammatory biomarkers (IL10, hsCRP) in women with postpartum depression
Public title
Effect of vitamin D and calcium supplementation on serum levels of hormones affecting postpartum depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Body mass index (BMI) less than 35; age 18 to 45years; earning a score of 12 and above in Edinburgh questionnaire; period range from 1 month until 6 months after child birth. Exclusion criteria: Normal or above normal range for vitamin D levels; chronic diseases such as diabetes; renal failure; gastrointestinal diseases; liver; thyroid; kidney stones; cancer in the past 5 years; birth abnormalities; taking contraceptive drugs; endocrine disorders; severe depression and other mental disorders; using antidepressants.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 81
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz, Iran.
City
Ahvaz
Postal code
6135715794
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.AJUMS.REC.1396.455

Health conditions studied

1

Description of health condition studied
F53.0
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium

Primary outcomes

1

Description
Interleukin 10
Timepoint
Before and after of 8 weeks intervention
Method of measurement
Seum level

2

Description
Cortisol
Timepoint
Before and after of 8 weeks intervention
Method of measurement
Seum level

3

Description
hsCRP
Timepoint
Before and after of 8 weeks intervention
Method of measurement
Seum level

Secondary outcomes

1

Description
Severity of apparent (situational) and hidden (characteristic) anxiety
Timepoint
Baseline and every 14 days for 8 weeks
Method of measurement
Spill Burger Questionnaire

2

Description
Blood pressure
Timepoint
Before the intervention, end of the fourth week and end of the eighth week
Method of measurement
Pressure gauge

3

Description
Weight
Timepoint
Before the intervention, end of the fourth week and end of the eighth week
Method of measurement
Scales

4

Description
Serum calcium
Timepoint
Before and after of 8 weeks intervention
Method of measurement
Seum level

5

Description
Waist Circumference
Timepoint
Before the intervention, end of the fourth week and end of the eighth week
Method of measurement
Inflexible meter

6

Description
Depression severity
Timepoint
Baseline and every 14 days for 8 weeks
Method of measurement
Edinburgh questionnaire

7

Description
Estradiol
Timepoint
Before and after of 8 weeks intervention
Method of measurement
Seum level

8

Description
Body Mass Index
Timepoint
Before the intervention, the end of the fourth week and and the end of the eighth week.
Method of measurement
Using the formula

Intervention groups

1

Description
50000 IU pearl vitamin D3, every 14 days + 500 milligram calcium carbonate tablet, daily, for 8 weeks
Category
Treatment - Drugs

2

Description
50000 IU pearl vitamin D3, every 14 days + calcium carbonate placebo, daily, for 8 weeks
Category
Treatment - Drugs

3

Description
Pearl paraffin as vitamin D placebo, every 14 days + calcium carbonate placebo, daily, for 8 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz West Health Center number 1
Full name of responsible person
Shirin Amini
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv, Ahvaz, Iran
City
Ahvaz

2

Recruitment center
Name of recruitment center
Sidon Health Center in Baghmalek City
Full name of responsible person
Shirin Amini
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv. Ahvaz, Iran.
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Sima Jafarirad
Position
PhD in Nutrition, Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv. Ahvaz, Iran.
City
Ahvaz
Postal code
6135715794
Phone
+98 613367543
Fax
+98 61 3373 8330
Email
sjafarirad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Judishapur University of Medical Scoences
Full name of responsible person
Sima Jafarirad
Position
PhD in nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv. Ahvaz.
City
Ahvaz
Postal code
6135715794
Phone
+98 61 3373 8317
Fax
Email
sjafarirad@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
Shirin Amini
Position
PhD candidate of Nutrition
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
00
Fax
Email
Aminishirin83@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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