The Supplementation effect of vitamin D on arterial function in patients with type 1 diabetes

The Supplementation effect of vitamin D on endothelial function in patients with type 1 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016112331062N1

Enrollment

Registered

2017-01-27

Start date

2017-02-03

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

diabetes mellitus type I. diabetes (mellitus): brittle juvenile-onset ketosis-prone type I

Interventions

Intervention 1: Patients in the in intervention group will receive 1000 IU of vitamin D every day for 12 weeks. Intervention 2: placebo will be taken by the control group.

Treatment - Drugs

Placebo

Patients in the in intervention group will receive 1000 IU of vitamin D every day for 12 weeks.

placebo will be taken by the control group.

Eligibility

Sex/Gender

All

Age

5 Years to 20 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: - Confirmed Type 1 diabetes mellitus - Age range of 5 to 20 years old - Without vitamin D deficiency (level of 25-hydroxyvitamin D> 30 nmol/L) - With disturbed FMD (2% change in FMD) Exclusion Criteria: - HbA1c = 8% - Hepatic dysfunction or malignancy - Uncontrolled hypertension (>140/90 mmHg)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Flow mediated dilation of the brachial artery. Timepoint: Initial of the study (Before intervention) and end of the study (After 12 weeks). Method of measurement: FMD measurement in this study will be done based on ACC guideline. The subject is positioned supine for 10 minutes with the arm in a comfortable position. First, anterior-posterior diameter of the right brachial artery is measured 3-5 centimeter above the antecubital fossa by using a Doppler Ultrasound probe and measurement location will be marked on the skin. For the next step, a sphygmomanometric cuff is placed on the forearm below the arterial scan location. The cuff is inflated to at least 250 mm Hg to occlude arterial inflow for 5 minutes. This causes ischemia of downstream resistance vessels. 45 – 60 seconds after cuff dilation, the longitudinal image of the brachial artery is recorded again on the same location as before to measure its anterior-posterior diameter. In the response to increase blood flow after induced ischemia, brachial artery dilates and this dilation depends on arterial endothelium.	—

Measure

Time frame

Flow mediated dilation of the brachial artery. Timepoint: Initial of the study (Before intervention) and end of the study (After 12 weeks). Method of measurement: FMD measurement in this study will be done based on ACC guideline. The subject is positioned supine for 10 minutes with the arm in a comfortable position. First, anterior-posterior diameter of the right brachial artery is measured 3-5 centimeter above the antecubital fossa by using a Doppler Ultrasound probe and measurement location will be marked on the skin. For the next step, a sphygmomanometric cuff is placed on the forearm below the arterial scan location. The cuff is inflated to at least 250 mm Hg to occlude arterial inflow for 5 minutes. This causes ischemia of downstream resistance vessels. 45 – 60 seconds after cuff dilation, the longitudinal image of the brachial artery is recorded again on the same location as before to measure its anterior-posterior diameter. In the response to increase blood flow after induced ischemia, brachial artery dilates and this dilation depends on arterial endothelium.

—

Secondary

Measure	Time frame
Fasting blood sugar. Timepoint: Begining of the study (Before the intervention) and End of the study (48 hours after final medicine usage). Method of measurement: Blood samples from all patients will be sent to the laboratory for glucose analysis.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Mardanshahi

Mazanadaran University of Medical Sciences

zmardanshahi@yahoo.com00

Outcome results

None listed

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