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How much thiamine is enough in malnourished patients receiving total parenteral nutrition?

Thiamine levels and duration of replacement in patients receiving total parenteral nutrition (TPN) with moderate to severe risk of refeeding - a prospective randomised controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000589684
Acronym
TIE
Enrollment
38
Registered
2023-05-30
Start date
2023-06-15
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

None listed

Brief summary

Thiamine deficiency manifests as two conditions: cardiac (wet) beriberi, or Wernicke’s encephalopathy. Furthermore, it can potentiate lactic acidosis through failure of pyruvate to enter the Kreb’s cycle. Patients who are malnourished are at risk of thiamine deficiency, and traditionally, replacement is given for patients at risk (patients on TPN without micronutrients, those with history of alcohol abuse, starvation states). Thiamine levels are not routinely checked in usual practice, but instead, supplementation is provided based on risk. The current guidelines give different recommendations (excluding for treatment of beriberi/Wernicke’s, in which the dose is 200-500mg intravenously three times a day for 5-7 days followed by 100mg for 1-2 weeks) 1. For those at high risk of thiamine deficiency, therapeutic guidelines suggests giving 300mg intravenously for 3 days and then 100mg daily for 1-2 weeks 2. In re-feeding syndrome 100mg intravenously for 7-10 days Clinical Question Is 3 days of intravenous thiamine replacement in patients receiving TPN AND at risk of refeeding syndrome, sufficient to restore and maintain thiamine levels when measured at day 7? Hypothesis In patients at risk of refeeding syndrome, thiamine levels are sufficiently restored with 3 days, as opposed to 7 days, of supplementation. Methodology Patients randomized to receive 3 days of intravenous thiamine or 7 days of intravenous thiamine. Standard dose will be given, 250mg b dose forte intravenous. Thiamine levels will be measured at day 0, 3 and 7 to ensure adequate blood levels are reached.

Interventions

Thiamine replacement (b dose forte brand) 250mg daily intravenously for 7 days

Sponsors

Sir Charles Gairdner Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Receiving total parenteral nutrition Ability to consent to participate or surrogate decision maker available Refeeding risk classified as moderate or severe as per 2020 American Society of Parenteral and Enteral Nutrition (ASPEN) refeeding syndrome guideline.

Exclusion criteria

Not at risk of re-feeding Unable to consent. Duration of TPN expected to be less than 7 days.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026