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Enrolling by invitation

NCT Number: NCT07781514

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bangladesh Medical University

Dhaka, Bangladesh

About this study

Hypothyroidism is a common endocrine disorder. It is characterized by deficient production of thyroid hormones, resulting in a generalized reduction in metabolic activity. It is commonly associated with symptoms such as fatigue, weight gain, cold intolerance, constipation, dry skin, menstrual disturbances and impaired cognitive function. Vitamin E has been shown to exert beneficial effect on oxidative stress markers.

Aim of the study: This study will aim to evaluate the effect of vitamin E supplementation as add on therapy on oxidative stress in levothyroxine treated hypothyroid patients.

Methodology: This is a single centred, double-blind, randomized placebo-controlled trial. Age ranged within 18-75, total of 74 patient will be assigned after fulfilling the inclusion and exclusion criteria, patients will be randomly assigned to receive either vitamin E supplementation or placebo for 12 weeks. Biochemical parameters, including TSH, FT4, glutathione, MDA, total antioxidant capacity, total oxidant status and oxidative stress index will be assessed at baseline and after intervention. The Chi-square test or Fisher's exact test will be employed to compare the percentage of participants may show a significant change in oxidative stress markers in the group that received vitamin E versus the group that received a placebo.

Conclusion: Combining vitamin E supplementation with levothyroxine could potentially have a substantial effect on thyroid hormone level and oxidative stress markers in hypothyroidism.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Vitamin E

Dietary Supplement

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

Placebo

Dietary Supplement

participants received vitamin E placebo orally once daily for 12 weeks

Primary outcomes

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

    Time frame: 12 weeks

  2. Change in Thyroid Stimulating Hormone level (mIU/L)

    Time frame: 12 weeks

  3. Changes in serum Glutathione (GSH)

    Time frame: 12 weeks

  4. Changes in total antioxidant capacity (TAC)

    Time frame: 12 weeks

  5. Changes in total oxidative status (TOS)

    Time frame: 12 weeks

  6. Changes in oxidative stress index (OSI)

    Time frame: 12 weeks

    No universal normal range

  7. Serum FT4 level

    Time frame: 12 weeks

Secondary outcomes

  1. • BMI

    Time frame: 12 weeks

Interested in participating?

Enrolling by invitation

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Official study title

Effect of Vitamin E as add-on Therapy on Thyroid Function and Oxidative Stress in Levothyroxine Treated Hypothyroid Patients: A Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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