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Study the effect of vitamin D supplements on type 2 diabetes

The effect of vitamin D supplements in diabetic retinopathy in type 2 diabetic patients

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180922041089N1
Enrollment
100
Registered
2019-01-24
Start date
2018-12-22
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic retinopathy. Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy

Interventions

Intervention 1: 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 ann

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Diabetic retinopathy. Timepoint: Start studying, 3months later, 6months later. Method of measurement: ETDRS scale.

Secondary

MeasureTime frame
Body mass index. Timepoint: Start studying, 6 months later. Method of measurement: measurement.;HA1C test. Timepoint: Start studying, 6 months later. Method of measurement: Laboratory measurement.;Macular thickness. Timepoint: Start studying, 6 months later. Method of measurement: OCT.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbolfazl Zendehdel

Tehran University of Medical Sciences

azendedel@sina.tums.ac.ir+98 21 5517 6031

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026