Protocol summary

Study aim
The purpose of this study is to determine the effect of Vitamin D oral supplementation on glycemic control, serum levels of Growth Hormone, Insulin-Like Growth Factor-1 and Lipid Profile in Gestational Diabetes Mellitus patients
Design
This is a randomized, double-blind, placebo-controlled clinical trial. The final sample includes 30 gestational diabetes patients who have been selected by convenience sampling method and will be placed randomly in two groups of intervention (n=15) and control (n=15). This study will be done within 6 weeks.
Settings and conduct
At the baseline and the end of study, blood samples will be collected and the growth hormone, Insulin-like growth factor-1, lipid profile and glycemic status in patients will be compared before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: detection of Gestational Diabetes Between 24-28 weeks of pregnancy, tend to participate in the study, age category between 18-40 years old, consumption of daily multivitamins; Exclusion criteria: twin or multiple pregnancy, having a Body Mass Index greater than 40, consumption of Vitamin D supplementation at least three months before the intervention, consumption of Insulin or Metformin, people with cardiovascular diseases, digestive disorders, hypertension, inflammatory diseases and hypothyroidism due to the effect on insulin metabolism and lipid profile.
Intervention groups
The intervention group will receive one tab containing 2000 IU vitamin D3 daily for 6 weeks; The control group will receive one plasebo containing paraffin oil daily for 6 weeks.
Main outcome variables
Vitamin D, growth hormone, insulin like growth factor-1, glucose, insulin, Cholesterol, triglyceride

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130616013678N29
Registration date: 2019-03-26, 1398/01/06
Registration timing: retrospective

Last update: 2019-03-26, 1398/01/06
Update count: 0
Registration date
2019-03-26, 1398/01/06
Registrant information
Name
Saeed Ghavamzadeh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1278 0803
Email address
ghavamzadeh_s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-11, 1397/05/20
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of vitamin D oral supplementation on glycemic control, serum levels of growth hormone, insulin-like growth factor-1 and lipid profile in gestational diabetes mellitus patients
Public title
Effect of vitamin D supplementation on control of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of gestational diabetes between 24-28 weeks of pregnancy Tend to participate in the study Age category between 18-40 years old Consumption of daily multivitamins
Exclusion criteria:
Twin or multiple pregnancy Having a body mass index greater than 40 Consumption of Vitamin D supplementation at least three months before the intervention Consumption of Insulin or Metformin People with cardiovascular diseases, digestive disorders, hypertension, inflammatory diseases and hypothyroidism Using cigarette and alcohol due to the effect on insulin metabolism and lipid profile
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Words of "intervention" and "control" will be writen on the 30 sheets and will be placed in Sealed envelope. Each patient will be asked to pick a envelope randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blinded clinical trial that participants are randomly classified into two groups of intervention and control and none of them know in which group they are. Researchers are unaware which participants are receiving the real treatment.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Orjhans street, Resalat Blvd, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-05-30, 1397/03/09
Ethics committee reference number
IR.UMSU.REC.1397.100

Health conditions studied

1

Description of health condition studied
Gestational Diabetes Mellitus
ICD-10 code
O24
ICD-10 code description
Diabetes Mellitus in pregnancy

Primary outcomes

1

Description
25 Hydroxy Vitamin D3
Timepoint
Before and 6 weeks after trials
Method of measurement
ElectroChemi Luminescence method

2

Description
Fasting Blood Sugar
Timepoint
Before and 6 weeks after trials
Method of measurement
Enzymatic method

3

Description
Serum Insulin
Timepoint
Before and 6 weeks after trials
Method of measurement
ELISA method

4

Description
Total Cholesterol
Timepoint
Before and 6 weeks after trials
Method of measurement
Enzymatic method

5

Description
Triglyceride
Timepoint
Before and 6 weeks after trials
Method of measurement
Enzymatic method

6

Description
LDL Cholesterol
Timepoint
Before and 6 weeks after trials
Method of measurement
Enzymatic method

7

Description
HDL Cholesterol
Timepoint
Before and 6 weeks after trials
Method of measurement
Enzymatic method

8

Description
Growth Hormone
Timepoint
Before and 6 weeks after trials
Method of measurement
ELISA method

9

Description
Insulin Like Growth Factor-1
Timepoint
Before and 6 weeks after trials
Method of measurement
ELISA method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Intervention group will receive a Vitamin D3 2000 IU supplement daily for the period of 6 weeks.
Category
Treatment - Other

2

Description
Control group: The control group will receive a placebo that is similar to Vitamin D supplements but contains Paraffin oil daily for the period of 6 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Midwifery clinic of Shahid Motahhari Hospital
Full name of responsible person
Fatemeh Mohammadi
Street address
Midwifery clinic of Shahid Motahhari Hospital, Ayatollah Kashani street, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 7077
Email
motahari@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Urmia University of Medical Sciences staffs department, Orjhans Street, Resalat Blvd, Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Saeid Ghavamzadeh
Position
PhD in Nutrition Science and associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th Km of Nazloo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3278 0803
Email
Ghavamzadeh_s@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr Saeid Ghavamz
Position
دکترای علوم تغذیه و دانشیار
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine , Urmia University of Medical Science, 11th Km of Nazloo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3278 0803
Email
Ghavamzadeh_s@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
ّFatemeh Mohammadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Faculty of Medicine, Urmia University of Medical Science, 11th Km of Nazloo Road, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3278 0803
Email
fatemeh.mohammadi128@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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