Pulse Dose versus Continuous Dose of Calciferol on Vascular Stiffness in Diabetic Kidney Disease: A Randomized Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20211004007

Enrollment

Registered

2021-10-04

Start date

2018-08-22

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Vascular stiffness in diabetic kidney disease. Calciferol, Chronic kidney disease, Pulse wave velocity.

Interventions

The pulse dose group received 200,000 IU (10 capsules of Calciferol) at 0 and 8 weeks. ,The continuous dose group received 40,000 IU (2 capsules) once a week for 8 weeks and 20,000 IU (1 capsule) once

Active Comparator Drug,Active Comparator Drug

Pulse dose group,Continuous dose group

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Vitamin D deficiency; serum 25(OH)D level equal to or less than 30 ng/ml 2. Diabetes mellitus type 2 (evidence of glycated hemoglobin level (HbA1C) equal to or more than 6.5% or 2 of fasting plasma glucose equal to or more than 126 mg/dL).

Exclusion criteria

Exclusion criteria: serum Calcium more than 10 mg/dL, serum Phosphorus more than 8 mg/dL, intact parathyroid hormone (iPTH) less than 15 ng/mL, or alkaline phosphatase (ALP) more than 3 times the upper normal limit, dialysis, kidney transplantation, peripheral arterial disease (radiologic findings or ankle-brachial index equal to or more than 0.9), active infection, pregnancy, and lactation, present or past malignancy, vitamin D (ergocalciferol or cholecalciferol) supplementation within the past 30 days, systolic blood pressure (BP) equal to or more than 160 mmHg or diastolic BP equal to or more than 100 mmHg, rheumatologic disease or loss to follow-up

Design outcomes

Primary

Measure	Time frame
Vascular stiffness at 0 and 10 weeks Carotid-femoral pulse wave velocity	—

Secondary

Measure	Time frame
CAVI at 0 and 10 weeks Cardio-ankle vascular index,25(OH)D at 0 and 10 weeks ng/ml / Blood sample,Intact parathyroid hormone at 0 and 10 weeks pg/ml / Blood sample,Serum creatinine at 0 and 10 weeks mg/dl / Blood sample,eGFR at 0 and 10 weeks ml/min/1.73m2 / CKD-EPI equation,Calcium at 0 and 10 weeks mg/dl / Blood sample,Phosphorus at 0 and 10 weeks mg/dl / Blood sample,Alkaline phosphatase at 0 and 10 weeks U/L / Blood sample,Urine albumin-creatinine ratio at 0 and 10 weeks mg/gCr / Urine sample,Systolic blood pressure at 0 and 10 weeks mmHg / sphymomanometer,Diastolic blood pressure at 0 and 10 weeks mmHg / sphymomanometer	—

Measure

Time frame

CAVI at 0 and 10 weeks Cardio-ankle vascular index,25(OH)D at 0 and 10 weeks ng/ml / Blood sample,Intact parathyroid hormone at 0 and 10 weeks pg/ml / Blood sample,Serum creatinine at 0 and 10 weeks mg/dl / Blood sample,eGFR at 0 and 10 weeks ml/min/1.73m2 / CKD-EPI equation,Calcium at 0 and 10 weeks mg/dl / Blood sample,Phosphorus at 0 and 10 weeks mg/dl / Blood sample,Alkaline phosphatase at 0 and 10 weeks U/L / Blood sample,Urine albumin-creatinine ratio at 0 and 10 weeks mg/gCr / Urine sample,Systolic blood pressure at 0 and 10 weeks mmHg / sphymomanometer,Diastolic blood pressure at 0 and 10 weeks mmHg / sphymomanometer

—

Countries

Thailand

Contacts

Public ContactNaphat Wutilertcharoenwong

Navamindradhiraj University

nwpuister@gmail.com0815424495

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026