HypothyroidismNCT07781514
Vitamin E Add-On Therapy, Thyroid Function & Oxidative Stress in Levothyroxine-Treated Hypothyroidism
A study testing vitamin E in people with Hypothyroidism, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBangladesh
- Study dates
- Feb 2027to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years up to 75 years
- Patient receiving Levothyroxine for at least 12 weeks
- Both male and female patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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.
- Conditions
- Hypothyroidism
- Being tested
- vitamin E, placebo
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin EDietary supplement
participants received vitamin E 400mg capsule orally once daily for 12 weeks
placeboDietary supplement
participants received vitamin E placebo orally once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E 400mg, participants received cap vitamin E 400mg orally once daily for 12 weeks | Experimental | Vitamin E capsule Alpha tocopherol, capsule, 400mg, 12weeks Receives: 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 Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Malondialdehyde (nmol/L) level from baseline to 12 weeks
Measured: 12 weeks
Change in Thyroid Stimulating Hormone level (mIU/L)
Measured: 12 weeks
Changes in serum Glutathione (GSH)
Measured: 12 weeks
Changes in total antioxidant capacity (TAC)
Measured: 12 weeks
Changes in total oxidative status (TOS)
Measured: 12 weeks
Changes in oxidative stress index (OSI)
No universal normal range
Measured: 12 weeks
Serum FT4 level
Measured: 12 weeks
Secondary outcomes (1)
• BMI
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startFeb 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fayeza Amrin Khan, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781514
- Sponsor's protocol ID
- BMU/2026/8020
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07781514
- Acronym / sponsor ID
- BMU/2026/8020
- Conditions
- Hypothyroidism
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin E 400mg, participants received cap vitamin E 400mg orally once daily for 12 weeks | Experimental | Dietary Supplement: vitamin EVitamin E capsule Alpha tocopherol, capsule, 400mg, 12weeks |
| participants received vitamin E placebo capsule matching vitamin E capsule orally once daily | Placebo comparator | Dietary Supplement: placeboVitamin E placebo capsule Capsule, 400mg, 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years up to 75 years
- Patient receiving Levothyroxine for at least 12 weeks
- Both male and female patient
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin Eparticipants received vitamin E 400mg capsule orally once daily for 12 weeks | Dietary supplement | Vitamin E 400mg, participants received cap vitamin E 400mg orally once daily for 12 weeks |
| placeboparticipants received vitamin E placebo orally once daily for 12 weeks | Dietary supplement | participants received vitamin E placebo capsule matching vitamin E capsule orally once daily |
Primary outcome
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)
Time frame: 12 weeks
No universal normal range
Serum FT4 level
Time frame: 12 weeks
1 secondary outcome
• BMI
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin E in people with Hypothyroidism, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Malondialdehyde (nmol/L) level from baseline to 12 weeks (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.