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Effect of 1-year cholecalciferol supplementation from early post-transplant preiod in kidney transplant recipients: a randomized controlled trial

Effect of 1-year cholecalciferol supplementation from early post-transplant preiod in kidney transplant recipients: a randomized controlled trial - Cholecalciferol supplementation from early period of kidney transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020597
Enrollment
200
Registered
2016-01-17
Start date
2016-01-17
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

kidney transplantation

Interventions

Oral Cholecalciferol 1 capsule containing 4000 IU/day Placebo

Sponsors

Nagoya Daini Red Cross Hospital
Lead Sponsor
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine Department of Pathophysiology, Tokyo Medical University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. eGFR >= 30 ml/min/1.73m2 2. <1 month after kidney transplantation 3. With written informed concent 4. Living kidney transplant recipients at Nagoya Red Cross Hospital

Exclusion criteria

Exclusion criteria: 1. On supplementation with native vitamin D (i.e., cholecalciferiol or ergocaliferol) 2. Corrected calcium >= 11.0 mg/dL 3. Patients judged to be inappropriate by the physician in charge

Design outcomes

Primary

MeasureTime frame
Change in estimated glomerular filtration rate at 1 year after KTx with adjustment for baseline values

Secondary

MeasureTime frame
1. Urinary kidney injury biomarkers (i.e., L-FABP and/or urinary protein/creatinine) at 6 months and 12 months after KTx 2. Pathophysiological findings on transplanted kidney at 12 months after KTx 3. Body compositions at 6 months and 12 months after transplantation 4. Bone metabolic markers and bone mineral density at 12 months after KTx 5. Prevalence of the development of hypercalcemia (corrected serum calcium>=11mg/dL) 6. Hospitalization-requiring infection-free survival

Countries

Japan

Contacts

Public ContactMakoto Tsujita

Nagoya Daini Red Cross Hospital Transplant Surgery

tsujita4850@yahoo.co.jp052-832-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026