Hypothyroidism
Conditions
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTvitamin E
participants received vitamin E 400mg capsule orally once daily for 12 weeks
DIETARY_SUPPLEMENTplacebo
participants received vitamin E placebo orally once daily for 12 weeks
Sponsors
Bangladesh Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 12 weeks | No universal normal range |
| Serum FT4 level | 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • BMI | 12 weeks |
Countries
Bangladesh
Outcome results
None listed