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

Phase 4

Completed

• Conditions: Vascular stiffness in diabetic kidney disease.; Calciferol, Chronic kidney disease, Pulse wave velocity.

• Registration Number: TCTR20211004007
• Lead Sponsor: avamindradhiraj University

Brief Summary

10 weeks of calciferol given to CKD patients with T2DM and 25(OH)D less than 30 ng/mL could achieve a more reduction of Cardio-ankle vascular index in the pulse dose than in the continuous dose groups. Although no statistically significant change in Carotid-femoral pulse wave velocity (cfPWV), there seemed to be a bigger cfPWV reduction in the pulse dose, with the achievement of 25(OH)D level.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-03-31
• Study Start: 2021-10-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular stiffness at 0 and 10 weeks Carotid-femoral pulse wave velocity

Secondary Outcome Measures

Name	Time	Method
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