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Effect of high dose vitamin B1 on early stage kidney disease in type 2 diabetes

A randomised, double-blind, placebo-controlled study to assess if high dose thiamine therapy of type diabetic patients with microalbuminuria decreases the urinary excretion of albumin Acronym: THIAMA

Status
Unknown
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2008/091/000112
Enrollment
40
Registered
2008-11-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Thiamine: 300 mg per day Control Intervention1: Placebo:

Sponsors

Sheikh Zayed Hospital Lahore Pakistan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 35-65 years old, Patients with type 2 diabetes and microalbuminuria (albumin excretion rate (AER) 30 - 299 mg/24 h), Diabetes duration of 5 years or more, Glycated haemoglobin HbA1c ≤12.5%, Body mass index (BMI) 19 - 40 kg/m2.

Exclusion criteria

Exclusion criteria: Allergy or intolerance to thiamine, Participation in another clinical study within the last 30 days, Women who are pregnant or breast feeding, Women of child bearing potential not using adequate contraceptive precautions, End stage renal disease (creatinine > 2mg/dl), Liver diseases (ASTP >3xULN, serum albumin <3.4 g/dl, acute hepatitis), and Any other significant morbidity.

Design outcomes

Primary

MeasureTime frame
Urinary excertion of albumin (24 h collection)Timepoint: Baseline; after 1, 2 and 3 months therapy; and after 1 and 2 months washout.

Secondary

MeasureTime frame
Plasma cholesterol and triglyceridesTimepoint: Baseline; after 1, 2 and 3 months therapy; and after 1 and 2 months washout.

Countries

Pakistan

Contacts

Public ContactDr Naila Rabbani

University of Warwick (UK)

N.Rabbani@warwick.ac.uk442476968593

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026