To determine the effect of vitamin D on insulin resistance index and fasting blood glucose in pregnant women
Design
A concealed, randomized, triple blind, controlled clinical trial with a parallel group design of 88 women, phase 3.
Settings and conduct
Sampling will be done in densely populated and socio-economically different centers of Malayer. Participants in the study will be assigned to two groups by stratified block randomization method (stratification based on deficient or insufficient serum levels of vitamin D) with block sizes of 4 and 6 and a allocation ratio of 1: 1 and using the website www.random.org . The allocation sequence will be identified by a person not involved in the study using a randomizer, and the 4,000-unit drug and placebo will be placed in the same packages numbered sequentially.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with gestational age of 8-10 weeks and vitamin D levels below 30 ng/ml
Exclusion criteria: Women with diabetes, thyroid and parathyroid disorders, history of macrosom neonate, body mass index above 30 kg/m2 before pregnancy, pre-pregnancy polycystic ovary syndrome and history of diabetes or gestational diabetes will be excluded from the study.
Intervention groups
The intervention group will receive 4 oral tablets of vitamin D 1000 units daily and the control group will receive placebo which is quite similar in appearance to the drug used in the intervention group.
Main outcome variables
Insulin Resistance Index
Serum level of fasting blood glucose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N59
Registration date:2020-11-04, 1399/08/14
Registration timing:prospective
Last update:2020-11-04, 1399/08/14
Update count:0
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Vitamin D on Insulin Resistance Biomarker and Fasting Blood Glucose in Pregnant Women: A Randomized Controlled Trial.
Public title
The effect of Vitamin D on fasting plasma glucose and Insulin levels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with gestational age of 8 -10 weeks
Vitamin D levels below 30 ng / ml
Exclusion criteria:
Women with diabetes
Vitamin D levels above 30 ng / ml
Women with thyroid and parathyroid disorders according to the self-report
Women with a history of macrosomic neonate
Women with a body mass index above 30 kg / m2 before pregnancy
Women with pre-pregnancy polycystic ovary syndrome, according to the self-report
Women with a history of diabetes or gestational diabetes
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the study will be assigned to two groups (one group receiving 4,000 units of oral vitamin D daily and one group receiving placebo with the same protocol) by stratified block randomization method (stratification based on deficient or insufficient serum levels of vitamin D) with block sizes of 4 and 6 and a allocation ratio of 1: 1 and using the website www.random.org . To hide the Allocation (Allocation Concealment), the allocation sequence will be identified by a person not involved in the study using a randomizer, and the 4,000-unit drug and placebo will be placed in the same packages numbered sequentially.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, researcher and data analyst will be blinded completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and packaging of drug and placebo will be conducted by a person not involved in the research.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-11-01, 1399/08/11
Ethics committee reference number
IR.TBZMED.REC.1399.759
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24.4
ICD-10 code description
Gestational diabetes mellitus
Primary outcomes
1
Description
Insulin resistance index
Timepoint
Before the intervention - 26 weeks of pregnancy
Method of measurement
HOMA-IR index
2
Description
Fasting plasma glucose levels
Timepoint
Before the intervention - 26 weeks of pregnancy
Method of measurement
FBS
3
Description
Fasting plasma insulin levels
Timepoint
Before the intervention - 26 weeks of pregnancy
Method of measurement
FBI
Secondary outcomes
1
Description
Abortion rate
Timepoint
26 weeks of pregnancy
Method of measurement
Abortion checklist
2
Description
Gestational Diabetes
Timepoint
26 weeks of pregnancy
Method of measurement
OGTT - FBS
3
Description
Depression score
Timepoint
26 weeks of pregnancy
Method of measurement
Edinburgh Depression Questionnaire
4
Description
Side effects
Timepoint
26 weeks of pregnancy
Method of measurement
Side effects checklist
Intervention groups
1
Description
The intervention group will receive 4000 units of oral vitamin D daily produced by Dana Pharmaceutical Company, which is quite similar in appearance to the drug used in the placebo group. This intervention will last for 17 weeks.
Category
Treatment - Drugs
2
Description
The control group will receive an oral placebo daily produced by Dana Pharmaceutical Company, which in terms of appearance is quite similar to the drug used in the intervention group. This study will last for 17 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Malayer city
Full name of responsible person
Zahra Mirzaee Azandaryani
Street address
Malayer city
City
Malayer
Province
Hamadan
Postal code
6578146769
Phone
+98 81 3231 2259
Email
z.mirzaee2019@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3479 6969
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Mirzaee Azandaryani
Position
MSc student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Email
z.mirzaee2019@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Email
mirghafourvandm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
South Shariati St. School of Nursing and Midwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3177 2048
Email
mirghafourvandm@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant data is confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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 results of the clinical trial will be published in the form of an article.
When the data will become available and for how long
Immediately after the publication of the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific use with reference to the article
From where data/document is obtainable
mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document