NCT00748618

Brief Summary

Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
11.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 26, 2024

Completed
Last Updated

October 26, 2024

Status Verified

August 1, 2024

Enrollment Period

3.5 years

First QC Date

September 4, 2008

Results QC Date

June 19, 2023

Last Update Submit

August 5, 2024

Conditions

Kidney TransplantationVitamin D Deficiency

Keywords

Kidney transplantation (KTX)Vitamin D deficiencyCardiovascular Disease (CVD)Vascular riskParathyroid hormone (PTH)Carotid intima media thickness (CIMT)Insulin resistance (IR)

Outcome Measures

Primary Outcomes (1)

  • Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.

    The 6 month change (6 month - Baseline) was compared between the two treatment arms of vitamin D supplements for normalizing vitamin D concentrations. Higher change values indicate improvement in vitamin D levels.

    Baseline and 6 months

Secondary Outcomes (4)

  • The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.

    baseline and 6 months

  • The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.

    6 months

  • The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.

    Baseline and 6 months

  • The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months

    Baseline and 6 months

Study Arms (2)

Standard vitamin treatment

OTHER

10,000 I.U. of vitamin D3 weekly

Dietary Supplement: Standard vitamin D3 treatment

50,000 I.U. of vitamin D3

ACTIVE COMPARATOR

50,000 I.U. of vitamin D3 weekly

Dietary Supplement: High dose vitamin D3 treatment

Interventions

Standard vitamin D3 treatmentDIETARY_SUPPLEMENT

10,000 I.U./wk of vitamin D3 orally for 6 months

Standard vitamin treatment
High dose vitamin D3 treatmentDIETARY_SUPPLEMENT

50,000 I.U./wk of vitamin D3 orally for 6 months

Also known as: D3, vitamin D
50,000 I.U. of vitamin D3

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney transplant more than 6 months ago
  • years or older
  • hydroxy vitamin D ≤35 ng/ml

You may not qualify if:

  • Estimated Glomerular filtration rate (GFR) \<30 ml/min/1.73m²
  • Previous small bowel or lung transplant
  • Pancreas transplant less than 6 months ago
  • Cancer or any condition that would change their weight dramatically in the near future such as malabsorption
  • Willing to return for testing every two months
  • Women who are pregnant or \< 6 weeks postpartum
  • Calcium \> 10.5 mg/dl
  • Phosphate \> 4.8 mg/dl
  • Drinking more than 2 alcohol drinks a day or 14 drinks per week
  • History of parathyroid surgery
  • Known granulomatous disease
  • Taking any seizure medication that affects vitamin D
  • Taking Zemplar ® and/or Rocaltrol ®
  • History of kidney stones in the past 20 years
  • Not on a stable dose of bisphosphonate for the past three months
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Vitamin D DeficiencyCardiovascular DiseasesInsulin Resistance

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Fang Yu
Organization
University of Nebraska Medical Center
fangyu@unmc.edu
(402) 559-9436

Study Officials

  • Jennifer L Larsen, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 8, 2008

Study Start

October 1, 2008

Primary Completion

April 1, 2012

Study Completion

June 8, 2023

Last Updated

October 26, 2024

Results First Posted

October 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)