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Effects of Different Doses of Vitamin D Supplementation on Pregnancy Outcomes in Gestational Diabetes women

Protocol summary

Summary
Objectives: Comparison of Effects Different Doses of Vitamin D Supplementation on Pregnancy Outcomes in Gestational Diabetes women. Design: Randomized, single-blind, ِDouble-center, phase II trial. Setting and conduct: For Group A, two times the baseline and day 21 of the study, vitamin IU D3 400 is administered.For Group B, two times the baseline and day 21 of the study, vitamin IU D3 50000 is administered.For Group Control, two times the baseline and day 21 of the study, placebo is administered. 10 days after delivery, outcomes pregnancy of patient is evaluated. Participants including major eligibility criteria: Inclusion criteria include: Pregnant women with gestational diabetes who have inadequate levels of vitamin D; exclusion criteria include: Irregular consumption of prescribed supplements. Intervention: For Group A, two times the baseline and day 21 of the study, vitamin IU D3 400 is administered.For Group B, two times the baseline and day 21 of the study, vitamin IU D3 50000 is administered.For Group Control, two times the baseline and day 21 of the study, placebo is administered. Main outcome measures variable: outcomes pregnancy after taking the supplements.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201604067520N2
Registration date: 2016-08-30, 1395/06/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-30, 1395/06/09
Registrant information
Name
Farahnaz Keshavarzi
Name of organization / entity
Kermanshah University of Medical Sciences (KUMS)
Country
Iran (Islamic Republic of)
Phone
+98 83 3724 2893
Email address
fnkeshavarzi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Different Doses of Vitamin D Supplementation on Pregnancy Outcomes in Gestational Diabetes women
Public title
Effects of Vitamin D Supplementation on Gestational Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Participants including major eligibility criteria: Inclusion criteria include: Pregnant women with gestational diabetes who have inadequate levels of vitamin D; exclusion criteria include: Irregular consumption of prescribed supplements.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 192
Randomization (investigator's opinion)
Not 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 Kermanshah University of Medical Sciences
Street address
Building No 2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Postal code
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
KUMS.REC.1394.261

Health conditions studied

1

Description of health condition studied
Consequences of postpartum
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination

Primary outcomes

1

Description
Birth weight
Timepoint
10 days after delivery
Method of measurement
By gram and a digital balance

2

Description
Birth height
Timepoint
10 days after delivery
Method of measurement
By cm and a centimeter standard

3

Description
Birth round head
Timepoint
10 days after delivery
Method of measurement
By cm and a centimeter standard

4

Description
Macrosomia
Timepoint
10 days after delivery
Method of measurement
By birth weight

5

Description
Apgar score at 1 and 5 minutes
Timepoint
10 days after delivery
Method of measurement
By apgar score

6

Description
Hypoglycemia
Timepoint
10 days after delivery
Method of measurement
By laboratory results

Secondary outcomes

empty

Intervention groups

1

Description
Vitamin IU D3 400, Baseline and day 21 of the study.
Category
Treatment - Drugs

2

Description
Vitamin IU D3 50000, Baseline and day 21 of the study.
Category
Treatment - Drugs

3

Description
Placebo, Baseline and day 21 of the study.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr Farahnaz Keshavarzi
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrozeh Hamzeh
Street address
Building No 2, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical sciences
Full name of responsible person
farahnaz Keshavarzi
Position
Specialist in obstetrics and gynecology
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3428 2668
Fax
Email
fnkeshavarzi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farahnaz Keshavarzi
Position
Obstetrics and gynecology specialist
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
+98 83 3428 2668
Fax
Email
fnkeshavarzi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Farzaneh Azizi
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of obstetrics and gynecology, Imam Reza Hospital, Sorkhalizheh.
City
Kermanshah
Postal code
Phone
00
Fax
Email
jhoseini2003@gmail.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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