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Effect of vitamin D supplementation on insulin resistance and inflammatory factors in women with gestational diabetes

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History
# Registration date Revision Id
3 2019-09-19, 1398/06/28 104166
2 2019-09-10, 1398/06/19 103176
1 2013-05-23, 1392/03/02 6037
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  • Primary outcomes

    #1
    empty
    Newborn's lengt
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    قد نوزادان
    empty
    Delivery time
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    زمان زایمان
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    Tape
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    متر نواری

  • Secondary outcomes

    #1
    empty
    Ponderal index
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    پوندرال ایندکس
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Calculation
    empty
    محاسبه
    #2
    empty
    Newborn's head circumference
    empty
    دور سر نوزادان
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Tape
    empty
    متر نواری
    #3
    empty
    Polyhydramnios
    empty
    پلی هیدروآمونیوس
    empty
    End-of-trial
    empty
    انتهای مداخله
    empty
    Sonographic
    empty
    سونوگرافی
    #4
    empty
    Calcium
    empty
    کلسیم
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #5
    empty
    Newborn's bilirubin
    empty
    بیلی روبین نوزادان تازه متولد شده
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #6
    empty
    Apgar score
    empty
    عدد آپگار
    empty
    Delivery time
    empty
    زمان زایمان
    empty
    Clinical observation
    empty
    مشاهده بالینی
    #7
    empty
    Newborns' hypoglycemia
    empty
    هیپوگلیسمی نوزادان تازه متولد شده
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Enzymatic kit
    empty
    کیت آنزیمی
    #8
    empty
    Preterm delivery
    empty
    زایمان زودرس
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #9
    empty
    Maternal pre-eclampsia
    empty
    پری اکلامپسی مادران باردار
    empty
    After delivery
    empty
    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #10
    empty
    Maternal hospitalization
    empty
    بستری شدن مادران
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    After delivery
    empty
    بعد زایمان
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    Medical record
    empty
    پرونده پزشکی
    #11
    empty
    Newborns' hospitalization
    empty
    بستری شدن نوزادان تازه متولد شده
    empty
    After delivery
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    بعد زایمان
    empty
    Medical record
    empty
    پرونده پزشکی
    #12
    empty
    LDL cholesterol
    empty
    LDL-کلسترول
    empty
    Baseline and End-of-trial
    empty
    ابتدا و انتهای مداخله
    empty
    Enzymatic kit
    empty
    کیت آنزیمی

  • Sponsors / Funding sources

    #1
    100
    50
    #2

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohammad Rafiei
    Full name of responsible person - Persian: محمد رفیعی
    Street address - English: Vice-chancellor for Education and Research, Sardasht Avenue, Arak
    Street address - Persian: اراك، خیابان سردشت، معاونت آموزش و تحقيقات
    City - English: Arak
    City - Persian: اراک
    Province: Isfehan
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3417 3639
    Fax:
    Email: research@arakmu.ac.ir
    Web page address:
    empty
    Yes
    empty
    50
    empty
    Public
    empty
    Domestic
    empty
    Academic
    empty
    Arak University of Medical Sciences
    empty
    دانشگاه علوم پزشکی اراک

Protocol summary

Study aim
The aim of this study is to determine the effects of vitamin D supplementation on insulin resistance, inflammatory factor and biomarkers of oxidative stress in gestational diabetes.
Design
Double-blind randomized controlled clinical trial
Settings and conduct
Among patients with gestational diabetes mellitus referred to maternity Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 54 patients will be selected according to inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria are including, pregnant women aged 18-40 years diagnosed with GDM at 24-28 weeks gestation. In addition, exclusion criteria are including, those with premature preterm rupture of membrane, placenta abruption, or preeclampsia; those who required commencing insulin therapy during intervention; those with hypothyroidism or urinary tract infection; those who smoked; those with kidney or liver diseases; and those taking estrogen therapy.
Intervention groups
Intervention group: Vitamin D supplements (Zahravi Pharm Company, Iran), 50000 IU, every 3 weeks for 6 weeks orally. Control group: Placebo supplements (Barij Essence, Kashan, Iran), every 3 weeks for 6 weeks orally
Main outcome variables
Serum levels of 25-hydroxyvitamin D (primary outcome), Fasting plasma glucose (FPG), serum insulin, insulin resistance, inflammatory factor and biomarkers of oxidative stress (secondary outcomes)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201305115623N7
Registration date: 2013-05-23, 1392/03/02
Registration timing: registered_while_recruiting

Last update: 2019-09-19, 1398/06/28
Update count: 2
Registration date
2013-05-23, 1392/03/02
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-05-15, 1392/02/25
Expected recruitment end date
2013-06-15, 1392/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on insulin resistance and inflammatory factors in women with gestational diabetes
Public title
Effect of vitamin D in treatment of gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18-40 years Women diagnosed with Gestational Diabetes Mellitus 24-28 weeks' gestation
Exclusion criteria:
Premature preterm rupture of membrane Placenta abruption Preeclampsia Those who required commencing insulin therapy during intervention Those with hypothyroidism Urinary tract infection Smoking Those with kidney or liver diseases Those taking estrogen therapy
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
To decrease potential confounding effects, all participants will have stratified randomization according to BMI and weeks of gestation. Then, participants in each block will be randomly allocated into two treatment groups to take either vitamin D supplement or placebo. Randomization will be done by the use of Stat Trek software. Participants, investigators or the assessors of the outcomes are also unaware of the study groups. https://stattrek.com/statistics/random-number-generator.aspx
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the maternity clinics affiliated with Kashan University of Medical Sciences, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. Supplements and placebo are in the same packaging at the Barij Essence pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Approval date
2013-05-14, 1392/02/24
Ethics committee reference number
P/29/5/1/605

Health conditions studied

1

Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified

Primary outcomes

1

Description
25-hydroxyvitamin D
Timepoint
Baseline and End-of-trial
Method of measurement
ELISA kit

2

Description
Newborn's lengt
Timepoint
Delivery time
Method of measurement
Tape

Secondary outcomes

1

Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

2

Description
Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry

3

Description
High-sensitivity C-reactive protein
Timepoint
Baseline and End-of-trial
Method of measurement
ELISA kit

4

Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
ELISA kit

5

Description
Insulin resistance
Timepoint
Baseline and End-of-trial
Method of measurement
Calculation using HOMA formula

6

Description
Triglycerides
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

7

Description
Total cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

8

Description
HDL
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

9

Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

10

Description
Ponderal index
Timepoint
Delivery time
Method of measurement
Calculation

11

Description
Newborn's head circumference
Timepoint
Delivery time
Method of measurement
Tape

12

Description
Polyhydramnios
Timepoint
End-of-trial
Method of measurement
Sonographic

13

Description
Calcium
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

14

Description
Newborn's bilirubin
Timepoint
Delivery time
Method of measurement
Enzymatic kit

15

Description
Apgar score
Timepoint
Delivery time
Method of measurement
Clinical observation

16

Description
Newborns' hypoglycemia
Timepoint
After delivery
Method of measurement
Enzymatic kit

17

Description
Preterm delivery
Timepoint
After delivery
Method of measurement
Medical record

18

Description
Maternal pre-eclampsia
Timepoint
After delivery
Method of measurement
Medical record

19

Description
Maternal hospitalization
Timepoint
After delivery
Method of measurement
Medical record

20

Description
Newborns' hospitalization
Timepoint
After delivery
Method of measurement
Medical record

21

Description
LDL cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic kit

Intervention groups

1

Description
Intervention group: Vitamin D3 capsule ( Zahravi Pharm Co, Iran), 50000 IU, every 3 weeks for 6 weeks orally.
Category
Treatment - Drugs

2

Description
Control group: Placebo capsule (Barij Essence Co, Iran), every 3 weeks for 6 weeks orally.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Maternity clinics affiliated with Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 0026
Email
beheshtihospital@kaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholamali Hamidi
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5554 2999
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Rafiei
Street address
Vice-chancellor for Education and Research, Sardasht Avenue, Arak
City
Arak
Province
Isfehan
Postal code
3848176941
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
50
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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutritionist
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 31 5562 0608
Email
asemi_r@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 36 1446 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
81151-87159
Phone
+98 36 1446 3378
Fax
Email
asemi_z@kaums.ac.ir
Web page address

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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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