Protocol summary

Study aim
Determining the Effect of Vitamin D Supplementation in Diabetic Retinopathy Determine the effect of vitamin D supplements on diabetic retinopathy according to the thickness of the macula Determine the effect of vitamin D supplements on diabetic retinopathy according to age Determine the effect of vitamin D supplements on the incidence of diabetic retinopathy according to sex Determination of the effect of vitamin D supplements on diabetic retinopathy according to HbA1C
Design
Clinical trial with interventional and control group, community-based and pragmatic, with parallel groups, blinded two-way
Settings and conduct
Patients with type 2 diabetes with a minimum age of 35 years are randomized by questioner in two groups by lottery.Two groups of patients receiving vitamin D (50) and a placebo control group (50 people) are divided into two groups. Patients in the target group receive 50,000 vitamin D units once every two weeks and to the placebo control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Age of at least 35 years. 2. Patients with type 2 diabetes who are treated with insulin or combined therapy Exclusion criteria 1- The history of any ocular disease (glaucoma, hypertensive retinopathy and cataract), or the history of eye surgery, or previous intra-ocular injections or visual acuity less than 6/10.2- History of chronic disease such as sarcoidosis, hyperparathyroidism and seizure, bone cancer or lung and liver cirrhosis and ...
Intervention groups
Patients with type 2 diabetes with a minimum age of 35 years are randomized by questioner in two groups by lottery. Patients are divided into two groups of recipients Vitamin 50 (D n) and placebo control group (50 people) are divided. Patients in the target group receive 50,000 vitamin D units once every two weeks and to the placebo control group.
Main outcome variables
Diabetic retinopathy

General information

Reason for update
Acronym
DRD
IRCT registration information
IRCT registration number: IRCT20180922041089N1
Registration date: 2019-01-24, 1397/11/04
Registration timing: registered_while_recruiting

Last update: 2019-01-24, 1397/11/04
Update count: 0
Registration date
2019-01-24, 1397/11/04
Registrant information
Name
Abolfazl Zendehdel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5517 6031
Email address
azendedel@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplements in diabetic retinopathy in type 2 diabetic patients
Public title
Study the effect of vitamin D supplements on type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of at least 35 years Patients with type 2 diabetes who are treated with insulin or combined therapy (insulin with antidiabetic pill) They have NPDRP without the need for specific ophthalmologic treatment interventions HbA1C levels below 8% Systolic blood pressure up to 130 Diastolic blood pressure is up to 80 mmHg Normal GFR is proportional to age based on MDRD formula The amount of 24-hour urine albumin is less than 300 milligrams.
Exclusion criteria:
The history of any ocular disease (glaucoma, hypertensive retinopathy and cataract), or the history of eye surgery, or previous intra-ocular injections or visual acuity less than 6/10 History of chronic disease such as sarcoidosis, hyperparathyroidism and seizure, bone cancer or lung and liver cirrhosis and... History of bariatric surgery or absorption disorders or any other disease indicating vitamin D intake. History of kidney stones Pregnancy and lactation History of taking phenofibrate, thiazolidinedione, anticonvulsants, or drugs that interfere with the metabolism of vitamin D or produce eye effects, including macular edema. The history of severe psychiatric illnesses such as schizophrenia, mood disorders, borderline disorders. Regular supplementation of D supplementation in the last three months or during the study (in the control group) History of any drug allergy or side effects. Participants are reluctant to take drugs or placebo Participate in another research project over the past 3 months HbA1C levels of 8% and more Glucocorticoid intake in the last 3 months BMI more than 35 The amount of 24-hour urine albumin exceeds 300 milligrams The GFR is greater than the normal range based on the age-appropriate MDRD formula.
Age
From 35 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation role method will be used. There are 30 green cards (interventions) and 30 orange cards (controls) inside white envelopes for women and the same number for men that were placed inside two separate lottery boxes and randomly each eligible patient will be assigned a card according to the sex.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate the bias caused by the patient's or doctor's knowledge of the received treatment type and its possible effect on the outcome of the study, the study is done in two blind ways. Considering that the vitamin D and placebo tablets are placed in the same capsule, the patient and the assessing physician are not aware of the type of received drug.
Placebo
Used
Assignment
Parallel
Other design features
Regarding the high prevalence of diabetes and the consequent increase in the prevalence of diabetic retinopathy in Iran and the growing health problem due to reduced visual acuity and blindness of the population with diabetic retinopathy, which is often active in working age, and preventable blindness due to Referring to the fact that family physicians are the first level of exposure to diabetic patients, if there is a positive result in this study, it is recommended that vitamin D supplements be used in all diabetic patients to prevent the development of diabetic retinopathy.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Abuzar St, Ziaian Hospital, Tehran Town
City
Tehran
Province
Tehran
Postal code
1366736511
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.258

Health conditions studied

1

Description of health condition studied
Diabetic retinopathy
ICD-10 code
E08.31
ICD-10 code description
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy

Primary outcomes

1

Description
diabetic retinopathy
Timepoint
Start studying, 3months later, 6months later
Method of measurement
ETDRS scale

Secondary outcomes

1

Description
body mass index
Timepoint
Start studying, 6 months later
Method of measurement
measurement

2

Description
HA1C test
Timepoint
Start studying, 6 months later
Method of measurement
Laboratory measurement

3

Description
Macular thickness
Timepoint
Start studying, 6 months later
Method of measurement
OCT

Intervention groups

1

Description
Intervention group: Patients with type 2 diabetes who are at least 35 years of age who are referred to an internal clinic or family physician are referred to an ophthalmologist for annual screening for diabetic retinopathy. During a visit, after 3 months of onset of the study, photogramography Digital Retinol is used to diagnose diabetic syringropathy. Patients in the target group treated with vitamin D were checked for vitamin D monitoring during the third month of their visit. Patients re-enter the specialty internists and ophthalmologists after 6 months of admission. The level of HbA1c marker hyalipid is checked and checked by an ophthalmologist and ophthalmologist, fluorosine angiography and OCT, and digital retinal photogramography for patients Done.
Category
Treatment - Drugs

2

Description
Control group: Patients with type 2 diabetes who are at least 35 years of age who are referred to an internal clinic or family physician are referred to an ophthalmologist for annual screening for diabetic retinopathy. The on-site, placebo-controlled, Once receive. All patients are followed up at the beginning of the study 3 months later and 6 months later by an intern doctor and an ophthalmologist.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Mansour ShaporSamaee
Street address
Abuzar St, Ziaian Hospital, Tehran Town
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Email
s.masamaei@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraeeian
Street address
Keshavarz Blvd - Qods St, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6130
Email
research-zia@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Grant Proposals
Proportion provided by this source
10
Public or private sector
Private
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
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Zendehdel
Position
Ziaian Hospital Education Assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Abuzar Street, Abuzar Square, opposite the 17th district of Ziaeean Hospital
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Fax
+98 21 5575 1333
Email
azendedel@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abolfazl Zendehdel
Position
Ziaian Hospital Education Assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Abuzar Street, Abuzar Square, opposite the 17th district of Ziaeean Hospital
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Fax
+98 21 5575 1333
Email
azendedel@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nassim Ebadati
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Abuzar St, Ziaian Hospital, Tehran Town
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6031
Email
nasimebadati@yahoo.com

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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