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Comparison of the effect of vitamin D supplementation on fasting plasma glucose and insulin resistance indices in pregnant women with gestational diabetes mellitus with a group of gestational diabetic pregnant women who do not receive vitamin D supplement

Protocol summary

Study aim
The aim of study is to determine the effect of vitamin D supplementation on declining insulin resistance and improving blood glucose control in pregnant women with gestational diabetes.
Design
This study is based on parallel triple blind randomized control trial.Randomization was done by block randomization method.The sample size is 44 in total.The trial is in Phase 3
Settings and conduct
The duration of intervention will be 6 weeks for each participant. Participants and investigators will be blind. Intervention group will receive 50,000 IU of oral vitamin D supplement twice (at baseline and at 21 days after intervention) in combination with oral calcium carbonate 1000 mg/ daily .The control group will receive placebo twice at baseline and at 21 days after intervention) with oral calcium carbonate 1000 mg tablet daily.The site of this study is the Endocrine Clinic of Hormozgan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women aged 18 to 40 After first trimester of pregnancy GDM diagnosis based on standard diagnostic test and confirmation of a obstetrician Tendency to attend the study. Exclusion criteria: Preeclampsia, insulin therapy, hypothyroidism, urinary infection diseases, smoking, renal and liver diseases
Intervention groups
Subjects in intervention groups will receive 50000 IU vitamin D3 supplement twice during the study (at baseline and at 21 days) along with 1000 mg/daily calcium carbonate supplement, and those in the placebo group Will receive 2 placebos at the same times and 1000 mg/daily calcium carbonate supplement.
Main outcome variables
Fasting plasma glucose, serum lipid profile (Triglyceride, Cholesterol, Low-density lipoprotein, High-density lipoprotein), blood level of vitamin D, plasma insulin level, blood calcium and phosphorus level, and insulin resistance will be assayed via calculating HOMA-IR

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150607022585N3
Registration date: 2018-09-22, 1397/06/31
Registration timing: retrospective

Last update: 2018-09-22, 1397/06/31
Update count: 0
Registration date
2018-09-22, 1397/06/31
Registrant information
Name
Masoumeh Kheirandish
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 761 2282
Email address
masoumeh.kheirandish@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2015-11-04, 1394/08/13
Expected recruitment end date
2016-08-18, 1395/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of vitamin D supplementation on fasting plasma glucose and insulin resistance indices in pregnant women with gestational diabetes mellitus with a group of gestational diabetic pregnant women who do not receive vitamin D supplement
Public title
Effect of vitamin D supplementation on fasting plasma glucose and insulin resistance indices in gestational diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women diagnosed with gestational diabetes at the age of 18-40 years. Pregnant women diagnosed with gestational diabetes who had not a previous history of overt diabetes. Pregnant women diagnosed with gestational diabetes who do not receive vitamin D supplement. Pregnant women diagnosed with gestational diabetes who do not smoke or do not use any drugs Pregnant women with gestational diabetes who do not have any systemic diseases including liver disease, hypertension, hypothyroidism. Pregnant women diagnosed with gestational diabetes who do not have multiple pregnancies Pregnant women diagnosed with gestational diabetes who do not take any medication which affect glucose metabolism like steroids and insulin Pregnant women diagnosed with gestational diabetes who do not take and medication any glucose lowering drugs.
Exclusion criteria:
unwillingness of participants to continue the study Start of insulin therapy during intervention miscarriage
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using software and block randomization method. The participants were divided into two groups: intervention and control.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding was carried out at the participant level, researchers, expert in the field and analysing the data
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethices Committee of Hormozgan University of Medical Sciences
Street address
Chamran Blvd. Hormozgan University of Medical Sciences
City
Bandar-Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2015-07-20, 1394/04/29
Ethics committee reference number
hums.REC.1394.026

Health conditions studied

1

Description of health condition studied
Gestational Diabetes Mellitus
ICD-10 code
E10-E14
ICD-10 code description
Diabetes Mellitus

Primary outcomes

1

Description
Fasting Plasma Glucose
Timepoint
at baseline of study- at the end of 6 weeks intervention
Method of measurement
commercial kit, enzymatic method

2

Description
انسولین سرم
Timepoint
at baseline of study- at the end of 6 weeks intervention
Method of measurement
immunoassay (Elisa) kit

3

Description
Insulin resistance index (HOMA-IR)
Timepoint
at baseline of study- at the end of 6 weeks intervention
Method of measurement
using formula

Secondary outcomes

1

Description
serum triglyceride
Timepoint
at study baseline and at the end of 6 weeks intervention
Method of measurement
enzymatic method by using commercial kit

2

Description
serum total cholesterol
Timepoint
at study baseline and at the end of 6 weeks intervention
Method of measurement
enzymatic method by using commercial kit

3

Description
LDL-C
Timepoint
at study baseline and at the end of 6 weeks intervention
Method of measurement
enzymatic method by using commercial kit

4

Description
HDL-C
Timepoint
at study baseline and at the end of 6 weeks intervention
Method of measurement
enzymatic method by using commercial kit

5

Description
Serum vitamin D concentration
Timepoint
at study baseline and at the end of 6 weeks intervention
Method of measurement
Commercial kit

6

Description
serum calcium
Timepoint
at study baseline and at the end of 6 weeks intervention
Method of measurement
Commercial kit

7

Description
Serum phosphorus
Timepoint
at study baseline and at the end of 6 weeks intervention
Method of measurement
Commercial kit

Intervention groups

1

Description
The control group received placebo twice (baseline and 21 days) in combination with calcium carbonate tablets 1000 milligram orally daily
Category
Placebo

2

Description
intervention group recieved 50,000 IU of oral vitamin D twice (baseline and 21 days) in combination with oral calcium carbonate 1000 milligram tablet daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Hormozgan University of Medical Science
Full name of responsible person
Kimia Seddighi
Street address
SHARIATI street, SEYYED JAMAL AD-DIN ASADABADI BLVD
City
Bandar-Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 71 3333 7192
Email
kheirandishm@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Nejatizadeh Abdolazim
Street address
Vice Chancellor for Research, Shahid Mohammadi Hospital, Jomhori Blvd.
City
Bandar-Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
mail@hums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
kimia Seddighi
Position
Internal Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Jomhori Blvd, shahid Mohammadi Hospital
City
Bandar-Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3222 0753
Fax
Email
kimia.seddighi@hums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Masoumeh Kheirandish
Position
Endocrinologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Jomhouri Bvd. Shahid Mohammadi Hospital
City
Bandar-Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3335 4056
Fax
Email
masoumeh.kheirandish@hums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Masoumeh Kheirandish
Position
Endocrinologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Jomhouri Bvd. Shahid Mohammadi Hospital
City
Bandar-Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3335 4056
Fax
Email
masoumeh.kheirandish@hums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
The main Outcomes will be shared after deidentified participants
When the data will become available and for how long
Data will become available after publication of the whole results of the study for one year
To whom data/document is available
Data will be accessible for researcher in universities, research centers and academic institutions
Under which criteria data/document could be used
The principal investigator of the trial, if other researchers need to more statistic analysis, after receiving the explicit request by electronic mail, will send the results of additional analysis to researchers through electronic mail.
From where data/document is obtainable
To receive documents contact with principal investigator through electronic mail. The main researcher: Dr masoumeh Kheirandish, Endocrinologist, Endocrine and Metabolism Research Center, Hormozgan University of Medical Sciences 1) Electronic Mail: Kheirandishm@yahoo.com masoumeh.kheirandish@hums.ac.ir 2) After publication of study, the results, study protocol, and more documents will be accessible in http://eprints.hums.ac.ir
What processes are involved for a request to access data/document
After Receiving the request through electronic mail, the principal investigator will immediately response to applicant, and based on the type of requested document, the exact time of sending the documents will be explain.
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