NCT04380467

Brief Summary

A pilot study to assess feasibility of methods of an observer-blinded randomised controlled trial of the effect of vitamin D supplementation in Chronic Kidney Disease and low vitamin D levels on markers of vascular function (Flow Mediated Dilatation of Brachial Artery), vascular structure (Carotid Intima Media Thickness) and Immune Regulation (frequencies of CD4+CD28null T lymphocytes ad Regulatory T lymphocytes).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 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

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

July 19, 2016

Last Update Submit

May 7, 2020

Conditions

AtherosclerosisChronic Kidney Disease

Keywords

Vitamin DCholecalciferolChronic Kidney DiseaseCardiovascular DiseaseAtherosclerosisFlow Mediated DilatationCarotid Intima Media ThicknessCD4+CD28null T lymphocyteRegulatory T lymphocyte

Outcome Measures

Primary Outcomes (6)

  • Recruitment rate

    Percentage of patients recruited from those eligible for the study.

    3 months

  • Retention rate

    Percentage of patients recruited who completed the follow up investigations

    6 months

  • Acceptability to patients of randomisation procedures

    Acceptability as assessed by quantitative and qualitative analysis of Participant Experience Survey

    6 months

  • Randomisation procedure

    Comparison of baseline indices of two patient groups

    6 months

  • Maintenance of single (observer) blinding

    Incidences of unblinding of study investigator

    6 months

  • Adherence to vitamin D supplementation

    Subjective adherence as assessed by Participant Experience Survey and biochemical correlation by comparison of follow up vitamin D levels

    6 months

Secondary Outcomes (3)

  • Witnessed change in FMD between treated and untreated subjects

    6 months

  • Witnessed change in CIMT between treated and untreated subjects

    6 months

  • Witnessed change in T lymphocyte subset frequency between treated and untreated subjects

    6 months

Study Arms (2)

Vitamin D Group

EXPERIMENTAL

Six doses of cholecalciferol 100,000units (5x aviticol 20,000units capsules) administered monthly over 20 weeks.

Dietary Supplement: Vitamin D (cholecalciferol)

Control

NO INTERVENTION

No vitamin D given

Interventions

Vitamin D (cholecalciferol)DIETARY_SUPPLEMENT

(aviticol) 5x 20,000unit capsules administered monthly over 20 weeks

Vitamin D Group

Eligibility Criteria

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

You may qualify if:

  • Age 18-80 years
  • Calcium \< 2.58mmol/l
  • On an ACE inhibitor/ARB
  • Vitamin D \<75nmol/l
  • eGFR 15- 60ml/min/1.73m2 and stable
  • Informed consent to participate

You may not qualify if:

  • Patients already on Vitamin D or calcium supplementation
  • Patients with known malignancies
  • Patients with autoimmune conditions
  • Patients with heart failure (ejection fraction \<40%, Plasma NT pro-BNP\>500pg/ml)
  • Patients with active infection
  • Rapidly deteriorating renal function
  • Recent Acute coronary syndrome or cerebro-vascular event (within the last 6 months)
  • Uncontrolled hypertension (BP\>160 systolic)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Debasish Banerjee

London, Tooting, sw17 0QT, United Kingdom

Location

MeSH Terms

Conditions

AtherosclerosisRenal Insufficiency, ChronicCardiovascular Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Debasish Banarjee

    St Georges University NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 19, 2016

First Posted

May 8, 2020

Study Start

January 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

GB(1)