Vitamin E Add-On Therapy, Thyroid Function & Oxidative Stress in Levothyroxine-Treated Hypothyroidism

NCT07781514 | Enrolling By Invitation

• 1 other identifier: BMU/2026/8020
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to learn if vitamin E supplementation as an adjunct to levothyroxine therapy help to reduce oxidative stress, improve antioxidant defence mechanisms, and favourably influence thyroid hormone status, making it a promising therapeutic strategy for patients with hypothyroidism. The findings from this investigation aim to establish an evidence-based framework for integrating targeted antioxidant therapies into standard hypothyroid management strategies.

Conditions

Hypothyroidism

Outcome Measures

Primary Outcomes (7)

• Change in Malondialdehyde (nmol/L) level from baseline to 12 weeks

  12 weeks

• Change in Thyroid Stimulating Hormone level (mIU/L)

  12 weeks

• Changes in serum Glutathione (GSH)

  12 weeks

• Changes in total antioxidant capacity (TAC)

  12 weeks

• Changes in total oxidative status (TOS)

  12 weeks

• Changes in oxidative stress index (OSI)

  No universal normal range

  12 weeks

• Serum FT4 level

  12 weeks

Secondary Outcomes (1)

• • BMI

  12 weeks

Study Arms (2)

Vitamin E 400mg, participants received cap vitamin E 400mg orally once daily for 12 weeks

EXPERIMENTAL

Vitamin E capsule Alpha tocopherol, capsule, 400mg, 12weeks

Dietary Supplement: vitamin E

participants received vitamin E placebo capsule matching vitamin E capsule orally once daily

PLACEBO COMPARATOR

Vitamin E placebo capsule Capsule, 400mg, 12 weeks

Dietary Supplement: placebo

Interventions

vitamin E DIETARY_SUPPLEMENT

participants received vitamin E 400mg capsule orally once daily for 12 weeks

Vitamin E 400mg, participants received cap vitamin E 400mg orally once daily for 12 weeks

placebo DIETARY_SUPPLEMENT

participants received vitamin E placebo orally once daily for 12 weeks

participants received vitamin E placebo capsule matching vitamin E capsule orally once daily

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years up to 75 years
• Patient receiving Levothyroxine for at least 12 weeks
• Both male and female patient

You may not qualify if:

• Pregnancy or lactating mother
• Suffering from active malignancy
• Known hypersensitivity to vitamin E
• Patient taking any other antioxidant drug
• Patients taking any antiplatelet or anticoagulant drug
• Patient with acute illness, liver disease, psychiatric disorder, hyperlipidemia

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Hypothyroidism

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)