Protocol summary

Summary
(1)Objectives: The effect of vitamin D3 supplementation on markers of metabolic and inflammatory markers in patients with diabetic nephropathy. (2) Design: Randomized Double blind clinical Trial, with a sample size of 50 patients. (3) Setting and conduct: After the patients participating, were randomly divided into 2 groups. The first blood samples were taken from the subjects after assessing their anthropometric measurements and taking their 3day food record. Then, they were asked to consume either of the Vitamin D3 or placebo for 8 weeks. More so, they were asked not to change their regular diet, activity and medicine during the study. Second Blood samples were also taken after an overnight fasting and before-after analysis was performed finally. (4) including major eligibility criteria: (4-a) Major Inclusion Criteria: With type 2 diabetes, blood glucose less than 140 mg/dl, stage 3 and 4 diabetic nephropathy and albuminuria more than 30 mg/day, the lack of proof for vitamin D is more than 15 ng/l and less than 30 ng/l. (4-b) Major Exclusion Criteria: Calcium and vitamin D supplements during the study, more than 2.5 mg/dL phosphorus, calcium modified more than 10 mg/dl, taking magnesium antacids, thiazide diuretics consumption.(5) Intervention: Group 1 (Intervention group) who weekly received 1 pearl containing 50000 unit cholecalciferol supplements after the lunch meal, and Group 2 (Placebo group) who received placebo as the same, all for 8 weeks. (6) Main outcome measures (Variables): Albuminuria, Fasting blood sugar, Serum insulin, TNFα, Interlukin6, Hemoglobin A1c, Blood pressure

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201511173140N15
Registration date: 2016-01-17, 1394/10/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-17, 1394/10/27
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
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of vitamin D3 supplementation on some of metabolic and inflammatory markers in patients with diabetic nephropathy
Public title
Effect of vitamin D3 in the treatment of patients with diabetic neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged between 20 to 50 years; have type 2 diabetes; control blood glucose less than 140 mg / dl; With BMI 20-35; stage 3 nad 4 diabetic nephropathy; albuminuria more than 30 mg per day; lack of proven vitamin D levels over 15 ng / l and less than 30 ng / l; Do not use calcium supplements and vitamin D in the last 3 months; Not taking medications that affect vitamin D metabolism, such as parathyroid hormone, estrogen, and calcitonin; willingness to cooperate Exclusion criteria: Changing the dose of the blood glucose lowering drugs; Change of medication or other treatment; taking calcium and vitamin D supplements during the study; with glomerulonephritis; Phosphorus more than 2/5 mg / dl; corrected calcium more than 10 mg / dl; active malignancy; The possibility of requiring renal replacement over the next year; uncontrolled high blood pressure; Taking antacids containing magnesium; Thiazide diuretics consumption; unwillingness to participate or to continue working
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Third floor, Central building No. 2, Tabriz University of Medical Sciences, Golgasht- street Tabriz
City
Tabriz
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
TBZMED.REC.1394.682

Health conditions studied

1

Description of health condition studied
diabetic nephropathy
ICD-10 code
E10
ICD-10 code description
With renal complications Diabetic nephropathy

Primary outcomes

1

Description
Albuminuria
Timepoint
Before and after intervention (8 weeks)
Method of measurement
Measurement of Albumin in urin by using kits

2

Description
Fasting blood glucose
Timepoint
Before and after intervention (8 weeks)
Method of measurement
Measurement of fasting blood glucose by using kits

3

Description
Hemoglobin A1c
Timepoint
Before and after intervention (8 weeks)
Method of measurement
Using ion exchange chromatography

4

Description
Insulin
Timepoint
Before and after intervention (8 weeks)
Method of measurement
Elisa

5

Description
TNF-α
Timepoint
Before and after intervention (8 weeks)
Method of measurement
Elisa

6

Description
Interlukin6
Timepoint
Before and after intervention (8 weeks)
Method of measurement
Elisa

7

Description
Added at 2016-02-16: Catalase activity
Timepoint
Added at 2016-02-16: Before and after intervention (8 weeks)
Method of measurement
Added at 2016-02-16: AEBI with using a UV/visbile spectrophotometer

Secondary outcomes

1

Description
blood pressure
Timepoint
Before and after intervention (8 weeks)
Method of measurement
pressure indicator

Intervention groups

1

Description
Control group: Receiving 1 placebo containing Miglyol oil weekly for 8 weeks.
Category
Placebo

2

Description
Intervention group: Receiving vitamin D3 supplement which contains 50,000 IU Pearl vitamin D3 cholecalciferol weekly for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital Endocrinology Clinic
Full name of responsible person
Asra Esfandiari
Street address
Daneshgah street, Golgasht street, Tabriz
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
Dr. AliReza Ostad Rahimi
Street address
Faculty of Nutrition, Attar street ,Golgasht street ,Tabriz
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
Faculty of Nutrition,Tabriz University of Medical Sciences,Tabriz
Full name of responsible person
Asra Esfandiari
Position
Health Sciences in nutrition graduate student
Other areas of specialty/work
Street address
Daneshgah street,Tabriz university of Medical sciences Tabriz
City
Tabriz
Postal code
Phone
+98 41 3281 9128
Fax
Email
asra.esfandiari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutrition,Tabriz University of Medical Sciences,Tabriz
Full name of responsible person
Dr,Bahram Pourghassem Gargari
Position
Ph.D. in Nutrition
Other areas of specialty/work
Street address
Daneshgah street,Tabriz university of Medical sciences Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 2117
Fax
Email
bahrampg@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nutrition,Tabriz University of Medical Sciences,Tabriz
Full name of responsible person
Asra Esfandiari
Position
Health Sciences in nutrition graduate student
Other areas of specialty/work
Street address
Tabriz university of Medical sciences, Daneshgah street, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
asra.esfandiari@gmail.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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