Hypothyroidism PrimaryPhase 3ViDaLLiTNCT06276205
Vitamin D & Levothyroxine Combination Versus Levothyroxine on Lipid Profile in Hypothyroidism
A Phase 3 study testing Vitamin D and Levothyroxin in people with Hypothyroidism Primary and Lipid Disorder, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment. The main question it aims to answer is: whether adding Vitamin D to standard therapy has any additional benefits Participants will be given Vitamin D in replacement doses according to their… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hypothyroidism Primary, Lipid Disorder, Dyslipidemias
- What is being tested?
- Vitamin D and Levothyroxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 1 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of all genders.
- Age more than 12 years
- Biochemically hypothyroid (overt \& subclinical)
- Vitamin D level between 10-70ng/ml
- TC <250mg/dl, LDL 70-144mg/dl, TGs 150-499mg/dl
Who cannot join
- Known Atherosclerotic Cardiovascular Disease
- BMI>35kg/m2
- History of Alcoholism (>14 units/day)
- History of Beta blocker intake
- Patient taking lipid lowering drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the Effectiveness of Vitamin D & Levothyroxine Combination Therapy and Levothyroxine Alone on Serum Lipid Profile in Patients With Hypothyroidism
The goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.
The main question it aims to answer is:
- whether adding Vitamin D to standard therapy has any additional benefits
Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.
Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them
- Conditions
- Hypothyroidism Primary, Lipid Disorder, Dyslipidemias
- Being tested
- Vitamin D, Levothyroxin
- Keywords
- levothyroxine, Vitamin D, Lipids, Hypothyroidism, Dyslipidemia
- Medical subject headings
- Hypothyroidism, Lipid Metabolism Disorders, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
if Vitamin D level suboptimal, 50,000 IU/week for 8 weeks followed by 2000 IU/d
if optimal Vitamin D level, 2000 IU/d
LevothyroxinDrug
Also called Thyroxine
commenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D + Levothyroxine | Experimental | Not described Receives: Drug: Vitamin D; Drug: Levothyroxin |
| Levothyroxine Alone | Active comparator | Not described Receives: Drug: Levothyroxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in Total Cholesterol
>9% decline from baseline
Measured: 24 weeks
Decline in LDL
14% decline in LDL-C from baseline >14% decline from baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothyroidism PrimaryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidrah Lodhi, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276205
- Sponsor's protocol ID
- 1037/RC/KEMU
- Acronym
- ViDaLLiT
- Status last verified
- Mar 2025
- First submitted
- 17 Feb 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Effectiveness of Vitamin D & Levothyroxine Combination Therapy and Levothyroxine Alone on Serum Lipid Profile in Patients With Hypothyroidism
- ClinicalTrials.gov ID
- NCT06276205
- Acronym / sponsor ID
- ViDaLLiT / 1037/RC/KEMU
- Conditions
- Hypothyroidism Primary, Lipid Disorder, Dyslipidemias
- Keywords
- levothyroxine, Vitamin D, Lipids, Hypothyroidism, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 23 Feb 2024 (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 goal of this clinical trial is to study the improvement of lipid levels in hypothyroid individuals after staring treatment.
The main question it aims to answer is:
- whether adding Vitamin D to standard therapy has any additional benefits
Participants will be given Vitamin D in replacement doses according to their pre-existing Vitamin D level in addition to levothyroxine.
Researchers will compare them with another group receiving only levothyroxine to see how much lipids improve in them
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D + Levothyroxine | Experimental | Drug: Vitamin D, Drug: Levothyroxin |
| Levothyroxine Alone | Active comparator | Drug: Levothyroxin |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of all genders.
- Age more than 12 years
- Biochemically hypothyroid (overt \& subclinical)
- Vitamin D level between 10-70ng/ml
- TC <250mg/dl, LDL 70-144mg/dl, TGs 150-499mg/dl
Key exclusion criteria (5 listed)
- Known Atherosclerotic Cardiovascular Disease
- BMI>35kg/m2
- History of Alcoholism (>14 units/day)
- History of Beta blocker intake
- Patient taking lipid lowering drugs
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 Dif Vitamin D level suboptimal, 50,000 IU/week for 8 weeks followed by 2000 IU/d if optimal Vitamin D level, 2000 IU/d | Drug | Vitamin D + Levothyroxine |
| LevothyroxinAlso: Thyroxinecommenced at a dose of 1.6mcg/kg/day and will be titrated 8 weekly according to response | Drug | Levothyroxine Alone, Vitamin D + Levothyroxine |
Primary outcome
Decline in Total Cholesterol
Time frame: 24 weeks
>9% decline from baseline
Decline in LDL
Time frame: 24 weeks
14% decline in LDL-C from baseline >14% decline from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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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. This study is not recruiting at the moment.
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 Phase 3 study testing Vitamin D and Levothyroxin in people with Hypothyroidism Primary and Lipid Disorder, run by King Edward Medical University at 1 site in Pakistan.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 11 Mar 2025. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decline in Total Cholesterol (time frame: 24 weeks). The study lists 2 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 11 Mar 2025.