An interventional study of vitamin E and placebo in Hypothyroidism, sponsored by Bangladesh Medical University. Enrolling by invitation at 1 site in Bangladesh. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Bangladesh Medical University · Not applicable, Interventional, and Supportive care
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.
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.
217 studies on the registry are indexed under Hypothyroidism; 50 are open to participants now.
This study's planned enrollment of 74 is close to the median of 70 across 109 interventional studies indexed under Hypothyroidism.
Browse Hypothyroidism studies →Bangladesh Medical University is the lead sponsor of 43 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vitamin E capsule Alpha tocopherol, capsule, 400mg, 12weeks
Dietary Supplement: vitamin E
Vitamin E placebo capsule Capsule, 400mg, 12 weeks
Dietary Supplement: placebo
participants received vitamin E 400mg capsule orally once daily for 12 weeks
participants received vitamin E placebo orally once daily for 12 weeks
Change in Malondialdehyde (nmol/L) level from baseline to 12 weeks
Time frame: 12 weeks
Change in Thyroid Stimulating Hormone level (mIU/L)
Time frame: 12 weeks
Changes in serum Glutathione (GSH)
Time frame: 12 weeks
Changes in total antioxidant capacity (TAC)
Time frame: 12 weeks
Changes in total oxidative status (TOS)
Time frame: 12 weeks
Changes in oxidative stress index (OSI)
No universal normal range
Time frame: 12 weeks
Serum FT4 level
Time frame: 12 weeks
• BMI
Time frame: 12 weeks
Plan to share: No
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Studies of the drug tested here: Vitamin E
Bangladesh Medical University