NCT00882401

Brief Summary

Overall research aims: This study will examine the effect of vitamin D supplementation on the function of the endothelium and microcirculation of patients with chronic kidney disease and vitamin D deficiency. Hypothesis: Vitamin D therapy in patients with CKD and concomitant vitamin D deficiency will improve endothelial, and therefore microcirculatory function, reduce levels of oxidative stress and thus reduce the risk of future CVS events in this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 22, 2011

Status Verified

March 1, 2011

Enrollment Period

1.5 years

First QC Date

April 15, 2009

Last Update Submit

March 21, 2011

Conditions

Chronic Kidney DiseaseVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Microcirculatory function - iontophoresis

    6 months

Secondary Outcomes (1)

  • Key clinical parameters of CKD management

    6 months

Study Arms (2)

Ergocalciferol (oral)

ACTIVE COMPARATOR

ergocalciferol: 50,000 IU per week for 1 month followed by 50,000 IU per month for 5 months.

Drug: Ergocalciferol (Vitamin D)

Placebo

PLACEBO COMPARATOR

Matching placebo at same dose schedule as ergocalciferol

Drug: Placebo

Interventions

Ergocalciferol (Vitamin D)DRUG

ergocalciferol: 50,000 IU per week for 1 month followed by 50,000 IU per month for 5 months.

Also known as: Drisdol
Ergocalciferol (oral)
PlaceboDRUG

Matching placebo at same dose schedule as ergocalciferol

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • eGFR between 15 and 60 ml/min/1.73m2
  • Serum 25 (OH) vitamin D levels \<30nmol/L
  • No evidence of diabetes mellitus (fasting blood sugar \<7.1, not taking any diabetic medication)
  • Not receiving haemo or peritoneal dialysis
  • No dialysis therapy within the last 3 months
  • Age \> 18 years and \< 80 years
  • Patient agrees not use any medications (prescribed or over-the-counter including herbal remedies) judged to be clinically significant by the Principal Investigator during the course of the study.
  • Able to understand and sign the written Informed Consent Form.
  • Able and willing to follow the Protocol requirements.

You may not qualify if:

  • Currently receiving oral ergocalciferol at any dose
  • Received IM ergocalciferol therapy within last 3 months
  • Receiving renal replacement therapy of any type or having recently received any form of dialysis (within 3 months)
  • Pacemaker or any other implanted cardiac device
  • Serum calcium above 2.6 mmol/L at screening
  • Pregnant or lactating
  • Known hypersensitivity to ergocalciferol
  • Patient known to have a condition which predisposes to hypercalcaemia (multiple myeloma, sarcoidosis, other granulomatous disease)
  • Initial blood pressure of \>160/100 mmHg
  • History of significant liver disease or cirrhosis
  • Anticipated requirement for dialysis in 6 months
  • Malabsorption, severe chronic diarrhea, or ileostomy
  • Known diagnosis of hypervitaminosis D
  • Known to have diabetes mellitus
  • Known to have renal calculi
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barts and the London NHS Trust

London, E1 1BB, United Kingdom

Location

Related Publications (1)

  • Dreyer G, Tucker AT, Harwood SM, Pearse RM, Raftery MJ, Yaqoob MM. Ergocalciferol and microcirculatory function in chronic kidney disease and concomitant vitamin d deficiency: an exploratory, double blind, randomised controlled trial. PLoS One. 2014 Jul 9;9(7):e99461. doi: 10.1371/journal.pone.0099461. eCollection 2014.

    PMID: 25006678DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicVitamin D Deficiency

Interventions

ErgocalciferolsVitamin D

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Officials

  • Magdi Yaqoob, MB ChB

    Barts and the London NHS Trust

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 16, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

March 22, 2011

Record last verified: 2011-03

Locations

GB(1)