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The effect of vitaminD3 supplementation on glucose and lipid profile, blood pressure, liver and kidney indices in overweight and obese (grade 1) patients with type2 diabetes

Protocol summary

Summary
This is a clinical, randomized and double blind trial which aims to determine the effect of vitaminD3 supplementation on blood glucose and lipid profile, blood pressure, liver and kidney indices in overweight and obese (grade 1) patients with type2 diabetes. After obtaining the informed consents, the researchers invite 90 male and female suffering from type2 diabetes aged 25 to 65 years in accordance with the inclusion criteria (serum 25 hydroxy vitaminD3 less than 30 ng/ml, BMI between 25 up to 35 kg/m², HbA1c level less than 8.5%) and exclusion criteria (insulin, pregnancy and lactation, the subjects' levels of triglyceride more than 250 mg/dl and cholesterol more than 300 mg/dl), they are all hospitalized in Besat Diabetic Clinic, Rasht and randomly divided into two treatment and placebo groups.The intervention group will use pearl of 50,000 IU of vitaminD3 every week and the placebo group pearl will have edible paraffin similar to vitaminD3 for 8 weeks. At the beginning and end of the study, glucose (Fasting blood Glucose and glycosylated hemoglobin) and lipid profile, liver and kidney indices, blood pressure, serum levels of 25 hydroxy vitaminD3, insulin resistance will be measured

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201605112365N12
Registration date: 2016-08-12, 1395/05/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-12, 1395/05/22
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Iran University of Medical Sciences
Expected recruitment start date
2016-07-31, 1395/05/10
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitaminD3 supplementation on glucose and lipid profile, blood pressure, liver and kidney indices in overweight and obese (grade 1) patients with type2 diabetes
Public title
The effect of vitamin D3 in the treatment of diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Diabetes type2 in both sexes; 25 to 65 years; Serum 25 hydroxy vitaminD3 levels less than 30 nano grams per milliliter (ng/ml); Body mass index (BMI) between 25 to 35 kilograms per square meter (kg/m²); glycated hemoglobin (HbA1c) level less than 8.5%; Willingness to participate in the project Exclusion criteria: Insulin consumption; Smoking or drinking alcohol at least once a week; Regular consumption of (at least once a week) herbal, antioxidant, multivitamin mineral, vitaminD3 and omega3 supplements; Taking birth control pills and Nonsteroidal antiiflammatory drugs (NSAIDs) in the last three months; Pregnancy and lactatin; Diagnosed diseases such as cancer, digestive diseases, liver and kidney diseases, autoimmune diseases, inflammation, hypothyroidism, polycystic ovarian syndrome; Changing usual and balanced diet with vegetarian diets or single product or any other unusual changes in the last three months; triglyceride levels more than 250 Milligrams per deciliter (mg/dl) and cholesterol more than 300 mg/dl; Exposure to sun and use of solarium for tanning up to 3 months before the start of the study; Taking medications affecting vitaminD3 metabolism such as Antiepileptic drugs and corticosteroids; Consuming less than 90% of supplements; Suffering from any acute illness; Any change in the type and amount of blood glucose lowering drugs
Age
From 25 years old to 65 years old
Gender
Both
Phase
3
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
The subjects will randomly assigned, through permuted blocked randomization (size=4)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
School of Public, Iran University of Medical Sciences, Hemat Express Way,Tehran
City
Tehran
Postal code
Approval date
2016-06-05, 1395/03/16
Ethics committee reference number
IR.IUMS.REC.1395.27871

Health conditions studied

1

Description of health condition studied
diabetes mellitus type2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
HbA1c
Timepoint
Before and 8 weeks after intervention
Method of measurement
Laboratory kit

2

Description
Fasting blood sugar
Timepoint
Before and 8 weeks after intervention
Method of measurement
Laboratory kit

3

Description
Lipid profile
Timepoint
Before and 8 weeks after intervention
Method of measurement
Laboratory kit

4

Description
Blood pressur
Timepoint
Before and 8 weeks after intervention
Method of measurement
Barometer

5

Description
liver indices
Timepoint
Before and 8 weeks after intervention
Method of measurement
Laboratory kit

6

Description
Kidney indices
Timepoint
Before and 8 weeks after intervention
Method of measurement
Laboratory kit

Secondary outcomes

1

Description
Serum 25(OH)D3 Level
Timepoint
Before and 8 weeks after intervention
Method of measurement
Laboratory Kit

2

Description
Fasting Insulin
Timepoint
Before and 8 weeks after intervention
Method of measurement
laboratory Kit

3

Description
Insulin resistance
Timepoint
Before and 8 weeks after intervention
Method of measurement
HOMA-IR formula

Intervention groups

1

Description
Pearl of vitaminD 50000IU weekly for 8 weeks
Category
Prevention

2

Description
Placebo of edible paraffin and similar to vitaminD3
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti Hospital diabetic clinic, Bandar Anzali
Full name of responsible person
Mohammad Reza Vafa
Street address
School of Public, Iran University of Medical Sciences, Hemat Express Way,Tehran
City
Bandar Anzali

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Dr Mohsen Asadi Lari
Street address
Vice Chancellor for research of Iran University of Medical Sciences, Hemat Express Way,Tehran
City
Tehran
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 of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Professor
Other areas of specialty/work
Street address
School of Public, Iran University of Medical Sciences, Hemat Express Way,Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
Rezavafa@yahoo.com; Rezavafa@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Professor
Other areas of specialty/work
Street address
School of Public, Iran University of Medical Sciences, Hemat Express Way,Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
Rezavafa@yahoo.com; Rezavafa@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Professor
Other areas of specialty/work
Street address
School of Public, Iran University of Medical Sciences, Hemat Express Way,Tehran
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
Rezavafa@yahoo.com; Rezavafa@iums.ac.ir
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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