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CompletedNCT04136119MiNuCritUpdated Mar 16, 2021

Micronutrients in Critically Ill Patients

An observational study in Nutrition, Critical Illness and Vitamin Supplementation, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Sex
All
01

Study summary

Nutritional support is an important component of modern critical care. The practice of vitamin and micronutrient supplementation is variable and official guidelines are not consistent. The primary objective of this observational study is to investigate the clinical practice of micronutrient supplementation during critical illness and to explore the factors underpinning clinical decisions.

Read the detailed description

Nutritional support is an integral component of modern critical care. Malnutrition is common, but measurement of serum concentrations of most vitamins and micronutrients does not form part of routine care for most critically ill adults in the UK. When measured in a research setting, a large proportion of critically ill patients have low serum concentrations of many essential nutrients. Nutrient deficiency is associated with adverse outcomes, including delirium and increased mortality. To date, it is unclear whether there is a role for micronutrient supplementation in critically ill patients. Official guidelines from the European Society of Parenteral and Enteral Nutrition (ESPEN), American Society of Parenteral and Enteral Nutrition (ASPEN), German Intensive Care Society and Kidney Disease Improving Global Outcome (KDIGO) vary and are contradictory to some extent. Additionally, vitamins B1 and C have been administered as an intervention in the treatment of septic shock and other disease states, but methodological flaws with such studies have left many clinicians with equipoise over the place of vitamin and micronutrients in clinical practice.

There is a need for a well designed, adequately powered intervention study. In preparation, we would like to explore current practice and decision making of doctors, pharmacists and dieticians who are directly involved in prescribing nutritional support.

The primary objective of this observational study is to investigate the clinical practice of micronutrient supplementation during critical illness and to explore the factors underpinning clinical decisions.

02

Conditions studied

  • Nutrition
  • Critical Illness
  • Vitamin Supplementation

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Keywords

  • micronutrient supplementation
  • vitamins
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 60 is below the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

health care professionals working in the ICU

Inclusion criteria

  • healthcare professional who is involved in prescribing vitamins or micronutrients to critically ill patients in the ICU

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • healthcare professionals

    doctors, pharmacists and dieticians who are involved in prescribing vitamins and micronutrients to critically ill patients

    Other: questionnaire

Interventions

  • Otherquestionnaire

    survey exploring practice of vitamin and micronutrient supplementation

06

What researchers measure

Primary outcomes

  1. clinical practice of vitamin supplementation

    indications for vitamin supplementation

    Time frame: October 2019 - April 2020

  2. clinical practice of micronutrient supplementation

    indications for micronutrient supplementation

    Time frame: October 2019 - April 2020

07

Study locations

1 site
  • Guy's & St Thomas Foundation Hospital
    London, SE1 7EH, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — individual participant data will not be made available

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04136119
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Responsible party
Sponsor
First posted
Oct 23, 2019
Start date
Nov 18, 2019
Primary completion
Feb 1, 2020
Completion
Dec 1, 2020
Last update
Mar 16, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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