Bangladesh Medical University
Dhaka, Bangladesh
NCT Number: NCT07781514
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Dhaka, Bangladesh
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
participants received vitamin E 400mg capsule orally once daily for 12 weeks
participants received vitamin E placebo orally once daily for 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
Time frame: 12 weeks
No universal normal range
Time frame: 12 weeks
Time frame: 12 weeks
Interested in participating?
Request InfoBangladesh Medical University
Other
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
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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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