NCT02869919

Brief Summary

This study aims to investigate whether there is a difference in Vitamin D levels between critically ill adult patients with and without acute kidney injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

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

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

3.2 years

First QC Date

May 16, 2016

Last Update Submit

October 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Vitamin D levels

    up to 28 days

Secondary Outcomes (2)

  • PTH levels

    up to 28 days

  • FGF23 levels

    up to 28 days

Study Arms (2)

Patients with AKI

critically ill patients with acute kidney injury

Other: AKI

Patients without AKI

critically ill patients without acute kidney injury

Other: AKI

Interventions

AKIOTHER

Vitamin D levels

Patients with AKIPatients without AKI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

critically ill patients in the Intensive Care Unit

You may qualify if:

  • age \>18 years presence of organ failure

You may not qualify if:

  • Chronic kidney disease stage 3b-5 Renal Transplant Vitamin D deficiency Vitamin D supplementation Hyperparathyroidism Treatment with total parenteral nutrition Life expectancy \<48 hours Patients with haemoglobin \<70g/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's & St Thomas Hospital

London, Greater London, SE1 7EH, United Kingdom

Location

Related Publications (2)

  • Cameron LK, Ledwaba-Chapman L, Voong K, Hampson G, Forni LG, Seylanova N, Harrington DJ, Lim R, Bociek A, Yanzhong W, Ostermann M. Vitamin D metabolism in critically ill patients with acute kidney injury: a prospective observational study. Crit Care. 2024 Apr 2;28(1):108. doi: 10.1186/s13054-024-04869-4.

  • Cameron LK, Lei K, Smith S, Doyle NL, Doyle JF, Flynn K, Purchase N, Smith J, Chan K, Kamara F, Kidane NG, Forni LG, Harrington D, Hampson G, Ostermann M. Vitamin D levels in critically ill patients with acute kidney injury: a protocol for a prospective cohort study (VID-AKI). BMJ Open. 2017 Jul 12;7(7):e016486. doi: 10.1136/bmjopen-2017-016486.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Marlies Ostermann, PhD

    Guy's & St Thomas Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

August 17, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

No We are not planning to make individual participant data available

Locations