Protocol summary

Summary
In this study, patients who suffered from gestational diabetes in the academic outpatient clinic at Alzahra Hospital of the Tabriz University of Medical Sciences, will be assessed in order to determine the Effects of vitamin D supplementation on serum vitamin D levels, markers of metabolic and inflammation in women with gestational diabetes. Inclusion criteria consists of: gestational diabetes; age between 15 and 45 years old and gestational age 24-28 weeks and exclusion criteria are: thyroid and parathyroid disorders, kidney disease, heart disease, hypertension, smoking and usage of nutritional supplements containing vitamin D in the past 6 months. 45 subjects will be divided into two groups randomly (taking the vitamin D supplement and control). Participants will receive 4 oral treatments consisting of 50000 IU of vitamin D3 (D-Vit 50 000; Zahravi Pharm Co, Tabriz, Iran), or a placebo (Zahravi Pharm Co), 1 every 2 weeks for 8 weeks. Every 2 weeks, vitamin D and placebo will be delivered to people. For each Patient questionnaire will be filled and general characteristics, anthropometric measurements (height and weight to calculate BMI) will be assessed. For each patient, 24-h recall questionnaire will be filled in order to assessment of energy, macronutrient and vitamin D intake for 3 days a week (2 working days and 1 holiday). These questionnaires will be completed at baseline and 8th week of the study. Ten ml blood sample from each patient will be taken after 12-14 hours fasting at the beginning and end of the intervention, and serum 25 OH vitamin D, fasting blood glucose levels, HbA1c, fasting serum insulin, insulin resistance, serum lipids and hs-CRP in both groups before and after the intervention will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306253140N11
Registration date: 2013-07-05, 1392/04/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-07-05, 1392/04/14
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation on serum vitamin D levels and markers of metabolic and inflammatory in women with gestational diabetes
Public title
Effect of vitamin D supplementation in the treatment of patients with gestational diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: gestational diabetes; age between 15 and 45 years old and gestational age 24-28 weeks. Exclusion criteria: thyroid and parathyroid disorders, kidney disease, heart disease, hypertension, smoking and usage of nutritional supplements containing vitamin D in the past 6 months.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
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 Tabriz University of Medical Sciences
Street address
Golbad Street, Tabriz University of Medical Sciences Golbad Street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2013-05-20, 1392/02/30
Ethics committee reference number
9249

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
Serum 25 (OH) vitamin D3
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
chemiluminescence immunoassay system

2

Description
Fasting blood glucose
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Enzymatic colorimetric

3

Description
serum Fasting insulin
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
chemiluminescence immunoassay system

4

Description
HbA1C (Glycosilated hemoglobin)
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Chromatography

5

Description
Insulin resistance
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
HOMA-IR calculation

6

Description
Total cholesterol
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Enzymatic methods

7

Description
Triglycerides
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Enzymatic methods

8

Description
HDL-Cholesterol
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Enzymatic methods

9

Description
high sensivity-C reactive protein
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Nephlometry

10

Description
LDL-Cholesterol,
Timepoint
Baseline and after 8 weeks of intervention
Method of measurement
Freidwald’s formula: LDL-C = TC- HDL-C - (TG/5)

Secondary outcomes

1

Description
Energy and macronutrients intake and vitamin D intake
Timepoint
before and after 8 weeks intervention
Method of measurement
24-h recall Questionnaire

2

Description
body nass index
Timepoint
before and after 8 weeks intervention
Method of measurement
weight(Kg)/Square Height

Intervention groups

1

Description
Intervention group will receive 4 oral vitamin D supplement capsules consisting of 50000 IU of vitamin D3 ) 1 every 2 weeks for 8 weeks. Vitamin D supplements will be purchased from the Zahravi Pharm Co. All the patients will receive the supplement on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews
Category
Treatment - Drugs

2

Description
The control group received 4 oral placebo (containing paraffin) 1 every 2 weeks for 8 weeks. Vitamin D supplements will be purchased from the Zahravi Pharm Co. All the patients will receive the supplement on every two weeks base and will be monitored for consumption continuation and any possible adverse effects by telephone interviews
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Academic outpatient clinic at Alzahra Hospital of the Tabriz University of Medical Sciences.
Full name of responsible person
Roya Yazdchi
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Seyed Kazem Shakouri
Street address
Golbad Street
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences, Faculty of Health and Nutrition
Full name of responsible person
doctor Bahram Poor Gaseme Gargari
Position
PHD in Nutrition Sciences
Other areas of specialty/work
Street address
Golgasht Street, St. Attar, School of Public Health Nutrition
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
bahrampg@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
doctor Bahram Poor gaseme Gargari
Position
PHD in Nutrition Sciences
Other areas of specialty/work
Street address
Golgasht Street, St. Attar, School of Public Health Nutrition
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
bahrampg@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roya Yazdchi
Position
MSc student in nutrition sciences
Other areas of specialty/work
Street address
Health and Nutrition faculty, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1334 8076
Fax
Email
Roya_yazdchi@yahoo.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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