Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D

Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01312441

Enrollment

Registered

2011-03-10

Start date

2011-01-31

Completion date

2015-08-31

Last updated

2016-01-14

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

Conditions

Renal Failure Chronic Requiring Hemodialysis, Vitamin D Deficiency

Keywords

Vitamin D, Ergocalciferol

Brief summary

The prevalence of vitamin D deficiency increases as kidney function declines. As a result, many hemodialysis patients often have low levels of vitamin D. Recent evidence has shown that vitamin D supplementation may improve many aspects of poor health such as heart disease and inflammatory markers. The objectives of this study are to determine how supplementing dialysis patients with ergocalciferol increases vitamin D levels, how long vitamin D levels can be maintained after a 6 month treatment course, and to examine the effect of ergocalciferol on biomarkers of inflammation and vascular health.

Interventions

DRUGErgocalciferol

Ergocalciferol capsules 50,000 IU once weekly for 6 months

DRUGPlacebo

Placebo by mouth once weekly for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years * Activated vitamin D administration * On chronic hemodialysis for ≥ 6 months * Use of a synthetic biocompatible dialysis membrane * 25-hydroxyvitamin D levels \< 30 ng/mL * Corrected serum calcium \< 10.2 mg/dL * Serum phosphate \< 7 mg/dL * Iron replete (Ferritin \> 200 ng/mL and transferrin saturation \> 20%)

Exclusion criteria

* Current participation in any other investigational drug trial * Vitamin D deficiency due to a heredity disorder * Liver disease or failure * Current or past treatment with ergocalciferol or cholecalciferol ≥ 2000 IU per day (within the past 6 months) * Treatment with calcimimetics or bisphosphonates within the last 3 months * Treatment with anti-epileptics or other medications that can effect vitamin D metabolism * Malnutrition (serum albumin \< 2.5 mg/dL) * Pregnancy, positive pregnancy test or breastfeeding * Malignancy or other significant inflammatory disease * HIV/AIDS

Design outcomes

Primary

Measure	Time frame
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026