Graves DiseasePhase 2NCT07369063
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
A Phase 2 study testing Ergocalciferol 50,000 IU and Methimazole in people with Graves Disease and Graves' Disease, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this randomized pilot feasibility clinical trial is to determine the feasibility of implementing a protocol for a larger trial to assess the effects of high-dose vitamin D supplementation in pediatric patients (9-17 years old) newly diagnosed with Graves' disease. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Graves Disease, Graves' Disease, Hyperthyroidism
- What is being tested?
- Ergocalciferol 50,000 IU and Methimazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 29 Oct 2026
- Phase
- Phase 2
- 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All new pediatric participants aged 9-17 years with a new diagnosis of GD who will be started on methimazole, will be offered to participate at the time of diagnosis.
- Biochemical features include:
- Suppressed TSH <0.1.
- Elevated T3
- Elevated Free T4
- Elevated T4
- Positive TSI or TRAb. The presence of antibodies is diagnostic.
- Our study will offer enrollment to non-English speaking participants
Who cannot join
- Initial hydroxy vitamin D levels >80 ng/mL
- Hypocalcemia, corrected calcium based on albumin <8.4 mg/dL
- Hypercalcemia, corrected calcium based on albumin >10.5 mg/dL
- Conditions that affect vitamin D metabolism such as: malabsorption, chronic kidney or liver disease, nephrocalcinosis, hyperparathyroidism
- Current use of medications which are known to affect thyroid function or vitamin D metabolism such as thyroid hormone replacement, corticosteroids, anticonvulsants
- Allergy to vitamin D or methimazole
Show all 10Show fewer
- Diagnosis of Hashitoxicosis or thyrotoxicosis (both TSH receptor antibody (TRAb) and thyroid-stimulating immunoglobulin (TSI) levels are negative)
- Participants under the age of 9 years at the time of diagnosis
- Pregnant participants
- Active or uncontrolled infections, other significant medical conditions deemed by the investigator to interfere with study participation or pose undue risk to the participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Endocrinology at Northwell Health
New Hyde Park, New York, 11042
About this study
Official title: Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease: A Pilot Feasibility Trial
The goal of this randomized pilot feasibility clinical trial is to determine the feasibility of implementing a protocol for a larger trial to assess the effects of high-dose vitamin D supplementation in pediatric patients (9-17 years old) newly diagnosed with Graves' disease. The main questions it aims to answer are:
What are the recruitment and adherence rates for a larger trial using this protocol? Is the data collection process complete and robust enough for a larger trial? What are the potential barriers to implementing a larger-scale trial? Researchers will compare vitamin D supplementation plus standard methimazole therapy to methimazole therapy alone (with participants permitted to take up to 1000 International Units of vitamin D2 daily) to explore potential effects on thyroid hormone and antibody levels.
Read more
Participants will:
Be randomized to either the intervention or control group. Take study medications (vitamin D or placebo) as directed. Attend regular study visits for blood tests and clinical assessments. Complete medication logs.
Read the detailed description
This pilot feasibility study will evaluate the practicality of conducting a larger randomized controlled trial (RCT) investigating the impact of high-dose vitamin D2 (ergocalciferol) supplementation as an adjunctive therapy to standard methimazole treatment in pediatric patients aged 9-17 years newly diagnosed with Graves' disease (GD). This study aims to address the current gap in research regarding vitamin D supplementation's effect on antibody and thyroid hormone trends in this population. Specifically, the study will examine the feasibility of recruitment, adherence to the intervention regimen, completeness of data collection, and any potential barriers to implementing a larger-scale trial.
The rationale for this study stems from the observed association between low vitamin D levels and an increased risk of Graves' disease, coupled with the limited data on vitamin D supplementation's influence on disease progression in children. This pilot study will investigate whether high-dose vitamin D supplementation, alongside methimazole, affects Thyroid Receptor Antibody (TRAb) and Thyroid Stimulating Immunoglobulin (TSI) antibody levels, as well as thyroid hormone levels (Total T3, Free Thyroxine, Total Thyroxine, TSH), in newly diagnosed pediatric GD patients.
Participants will be randomized 1:1 to either an intervention arm (methimazole + high-dose vitamin D2) or a control arm (methimazole only, with the option of taking up to 1000 IU/day of vitamin D2). The intervention arm will receive 50,000 IU of vitamin D2 weekly for 8 weeks, followed by 50,000 IU every two weeks for 16 weeks, along with standard methimazole therapy as directed by their treating endocrinologist. The control arm will receive standard methimazole therapy alone, per their physician's orders, with the option of taking up to 1000 IU of Over-the-counter (OTC) vitamin D2 daily, if desired. The study will not provide this OTC vitamin D.
The primary feasibility outcomes will be: (1) recruitment rate; (2) adherence rate to the vitamin D supplementation, assessed through pill counts, medication logs, and self-report; (3) data completeness; and (4) identification of any barriers encountered during study implementation. Exploratory clinical outcomes will include time to normalization of thyroid function tests and the percentage change from baseline in TRAb and TSI antibody levels at 24 weeks. Safety and tolerability will be closely monitored, with particular attention to hypercalcemia and hypervitaminosis D. Data on adverse events will be collected and graded using the CTCAE v5.0.
Data analysis will primarily focus on descriptive statistics for feasibility outcomes. Exploratory clinical outcomes will be analyzed to estimate effect sizes and variability, informing the design of a future, adequately powered RCT. This pilot study is not powered to detect statistically significant differences in clinical outcomes.
This study will provide critical preliminary data and feasibility metrics to inform the development of a larger, more definitive RCT evaluating vitamin D's efficacy as an adjunctive therapy in pediatric Graves' disease. This research has the potential to significantly advance our understanding of the role of vitamin D in autoimmune thyroid disease and contribute to improved treatment strategies for children with Graves' disease.
The FDA has granted an Investigational New Drug (IND) exemption (PIND 176865, dated April 30, 2025) for this pilot feasibility study evaluating high-dose vitamin D2 in children with Graves' disease. The exemption allows the study to proceed without a full IND application.
- Conditions
- Graves Disease, Graves' Disease, Hyperthyroidism
- Being tested
- Ergocalciferol 50,000 IU, Methimazole
- Keywords
- vitamin d, graves disease, hyperthyroidism
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol 50,000 IUDrug
Participants will receive ergocalciferol 50,000 IU oral capsules weekly for the first 8 weeks, followed by 50,000 IU every two weeks for the subsequent 16 weeks (total 24 weeks).
MethimazoleDrug
Methimazole is considered standard of care for pediatric Graves' disease. Dosing is determined and adjusted by the participant's treating physician
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Vitamin D2 + Methimazole | Experimental | Participants in this arm will receive methimazole at a dose determined by their treating physician, according to standard clinical practice guidelines for pediatric Graves' disease. In addition, they will receive high-dose vitamin D2 (ergocalciferol) 50,000 IU orally weekly for the first 8 weeks, followed by 50,000 IU orally every two weeks for the remaining 16 weeks of the study. Receives: Drug: Ergocalciferol 50,000 IU; Drug: Methimazole |
| Methimazole (with optional low dose Vitamin D2) | Placebo comparator | Participants in this arm will receive methimazole at a dose determined by their treating physician, according to standard clinical practice guidelines for pediatric Graves' disease. Participants will have the option of taking up to 1000 IU of vitamin D2 daily, purchased over-the-counter, but this will not be provided by the study. This is to address potential vitamin D deficiency while maintaining a comparison group. Receives: Drug: Methimazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Metrics: Recruitment Rate
Percentage of eligible participants approached who consent to participate in the study. This metric will assess the efficiency of recruitment strategies.
Measured: through study completion, an average of 1 yea
Feasibility Metrics: Adherence Rate
Percentage of prescribed vitamin D doses taken by participants in the intervention arm. Adherence will be tracked via pill counts and participant self-report.
Measured: From enrollment to 24 week/6month follow up visit
Feasibility Metrics: Data Completeness
Percentage of completed data fields for key outcome measures (thyroid function tests, TSI levels, etc.). This will assess the quality and completeness of data collection.
Measured: From baseline data collection to the 24-week/6-month follow-up visit.
Feasibility Metrics: Implementation Barriers
A qualitative assessment of any challenges encountered during the study implementation (e.g., recruitment difficulties, adherence issues, logistical problems). This assessment will inform strategies for overcoming these barriers in a future, larger-scale RCT.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Time to Normalization and Thyroid function Trends
We hypothesize that patients receiving high-dose vitamin D will achieve normal TSH, T3, Free T4 and T4 levels significantly faster than those receiving methimazole alone. Thyroid function tests will be measured at baseline, 6, 12 and 24 weeks, and time to normalization will be compared between groups.
Measured: from enrollment to 24 week/6month follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start25 Aug 2025
- Primary completion29 Oct 2026 (estimated)
- Study completion29 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The control group receives standard methimazole therapy and has the option of taking up to 1000 IU/day of over-the-counter vitamin D2, which is not provided by the study. This is to ensure ethical considerations related to vitamin D deficiency are met while maintaining a comparison group. Should the patients in the control group have vitamin D levels \<20 ng/mL, patients will be strongly advised to take the 1000 IU of vitamin D daily for repletion.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Hyman, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369063
- Sponsor's protocol ID
- 25-0285
- Status last verified
- Oct 2026
- First submitted
- 14 Jul 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data from this pilot feasibility study will not be shared immediately due to the small sample size and the increased risk of participant re-identification. However, data sharing aligned with journal requirements will be considered upon publication of the study results. A detailed data sharing plan will be developed at that time, addressing ethical considerations and ensuring participant privacy while maximizing the scientific value of the data. This plan will outline the specific data to be shared (e.g., de-identified data, specific variables) and the process for requesting access.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease: A Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT07369063
- Acronym / sponsor ID
- 25-0285
- Conditions
- Graves Disease, Graves' Disease, Hyperthyroidism
- Keywords
- vitamin d, graves disease, hyperthyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 29 Oct 2026 (estimated)
- Study completion
- 29 Oct 2026 (estimated)
- First posted
- 27 Jan 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 goal of this randomized pilot feasibility clinical trial is to determine the feasibility of implementing a protocol for a larger trial to assess the effects of high-dose vitamin D supplementation in pediatric patients (9-17 years old) newly diagnosed with Graves' disease. The main questions it aims to answer are:
What are the recruitment and adherence rates for a larger trial using this protocol? Is the data collection process complete and robust enough for a larger trial? What are the potential barriers to implementing a larger-scale trial? Researchers will compare vitamin D supplementation plus standard methimazole therapy to methimazole therapy alone (with participants permitted to take up to 1000 International Units of vitamin D2 daily) to explore potential effects on thyroid hormone and antibody levels.
Participants will:
Be randomized to either the intervention or control group. Take study medications (vitamin D or placebo) as directed. Attend regular study visits for blood tests and clinical assessments. Complete medication logs.
Detailed description
This pilot feasibility study will evaluate the practicality of conducting a larger randomized controlled trial (RCT) investigating the impact of high-dose vitamin D2 (ergocalciferol) supplementation as an adjunctive therapy to standard methimazole treatment in pediatric patients aged 9-17 years newly diagnosed with Graves' disease (GD). This study aims to address the current gap in research regarding vitamin D supplementation's effect on antibody and thyroid hormone trends in this population. Specifically, the study will examine the feasibility of recruitment, adherence to the intervention regimen, completeness of data collection, and any potential barriers to implementing a larger-scale trial.
The rationale for this study stems from the observed association between low vitamin D levels and an increased risk of Graves' disease, coupled with the limited data on vitamin D supplementation's influence on disease progression in children. This pilot study will investigate whether high-dose vitamin D supplementation, alongside methimazole, affects Thyroid Receptor Antibody (TRAb) and Thyroid Stimulating Immunoglobulin (TSI) antibody levels, as well as thyroid hormone levels (Total T3, Free Thyroxine, Total Thyroxine, TSH), in newly diagnosed pediatric GD patients.
Participants will be randomized 1:1 to either an intervention arm (methimazole + high-dose vitamin D2) or a control arm (methimazole only, with the option of taking up to 1000 IU/day of vitamin D2). The intervention arm will receive 50,000 IU of vitamin D2 weekly for 8 weeks, followed by 50,000 IU every two weeks for 16 weeks, along with standard methimazole therapy as directed by their treating endocrinologist. The control arm will receive standard methimazole therapy alone, per their physician's orders, with the option of taking up to 1000 IU of Over-the-counter (OTC) vitamin D2 daily, if desired. The study will not provide this OTC vitamin D.
The primary feasibility outcomes will be: (1) recruitment rate; (2) adherence rate to the vitamin D supplementation, assessed through pill counts, medication logs, and self-report; (3) data completeness; and (4) identification of any barriers encountered during study implementation. Exploratory clinical outcomes will include time to normalization of thyroid function tests and the percentage change from baseline in TRAb and TSI antibody levels at 24 weeks. Safety and tolerability will be closely monitored, with particular attention to hypercalcemia and hypervitaminosis D. Data on adverse events will be collected and graded using the CTCAE v5.0.
Data analysis will primarily focus on descriptive statistics for feasibility outcomes. Exploratory clinical outcomes will be analyzed to estimate effect sizes and variability, informing the design of a future, adequately powered RCT. This pilot study is not powered to detect statistically significant differences in clinical outcomes.
This study will provide critical preliminary data and feasibility metrics to inform the development of a larger, more definitive RCT evaluating vitamin D's efficacy as an adjunctive therapy in pediatric Graves' disease. This research has the potential to significantly advance our understanding of the role of vitamin D in autoimmune thyroid disease and contribute to improved treatment strategies for children with Graves' disease.
The FDA has granted an Investigational New Drug (IND) exemption (PIND 176865, dated April 30, 2025) for this pilot feasibility study evaluating high-dose vitamin D2 in children with Graves' disease. The exemption allows the study to proceed without a full IND application.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The control group receives standard methimazole therapy and has the option of taking up to 1000 IU/day of over-the-counter vitamin D2, which is not provided by the study. This is to ensure ethical considerations related to vitamin D deficiency are met while maintaining a comparison group. Should the patients in the control group have vitamin D levels <20 ng/mL, patients will be strongly advised to take the 1000 IU of vitamin D daily for repletion.
| Arm | Type | Receives |
|---|---|---|
| High-Dose Vitamin D2 + Methimazole | Experimental | Drug: Ergocalciferol 50,000 IU, Drug: MethimazoleParticipants in this arm will receive methimazole at a dose determined by their treating physician, according to standard clinical practice guidelines for pediatric Graves' disease. In addition, they will receive high-dose vitamin D2 (ergocalciferol) 50,000 IU orally weekly for the first 8 weeks, followed by 50,000 IU orally every two weeks for the remaining 16 weeks of the study. |
| Methimazole (with optional low dose Vitamin D2) | Placebo comparator | Drug: MethimazoleParticipants in this arm will receive methimazole at a dose determined by their treating physician, according to standard clinical practice guidelines for pediatric Graves' disease. Participants will have the option of taking up to 1000 IU of vitamin D2 daily, purchased over-the-counter, but this will not be provided by the study. This is to address potential vitamin D deficiency while maintaining a comparison group. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- All new pediatric participants aged 9-17 years with a new diagnosis of GD who will be started on methimazole, will be offered to participate at the time of diagnosis.
- Biochemical features include:
- Suppressed TSH <0.1.
- Elevated T3
- Elevated Free T4
Key exclusion criteria (10 listed)
- Initial hydroxy vitamin D levels >80 ng/mL
- Hypocalcemia, corrected calcium based on albumin <8.4 mg/dL
- Hypercalcemia, corrected calcium based on albumin >10.5 mg/dL
- Conditions that affect vitamin D metabolism such as: malabsorption, chronic kidney or liver disease, nephrocalcinosis, hyperparathyroidism
- Current use of medications which are known to affect thyroid function or vitamin D metabolism such as thyroid hormone replacement, corticosteroids, anticonvulsants
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 |
|---|---|---|
| Ergocalciferol 50,000 IUParticipants will receive ergocalciferol 50,000 IU oral capsules weekly for the first 8 weeks, followed by 50,000 IU every two weeks for the subsequent 16 weeks (total 24 weeks). | Drug | High-Dose Vitamin D2 + Methimazole |
| MethimazoleMethimazole is considered standard of care for pediatric Graves' disease. Dosing is determined and adjusted by the participant's treating physician | Drug | High-Dose Vitamin D2 + Methimazole, Methimazole (with optional low dose Vitamin D2) |
Primary outcome
Feasibility Metrics: Recruitment Rate
Time frame: through study completion, an average of 1 yea
Percentage of eligible participants approached who consent to participate in the study. This metric will assess the efficiency of recruitment strategies.
Feasibility Metrics: Adherence Rate
Time frame: From enrollment to 24 week/6month follow up visit
Percentage of prescribed vitamin D doses taken by participants in the intervention arm. Adherence will be tracked via pill counts and participant self-report.
Feasibility Metrics: Data Completeness
Time frame: From baseline data collection to the 24-week/6-month follow-up visit.
Percentage of completed data fields for key outcome measures (thyroid function tests, TSI levels, etc.). This will assess the quality and completeness of data collection.
Feasibility Metrics: Implementation Barriers
Time frame: through study completion, an average of 1 year
A qualitative assessment of any challenges encountered during the study implementation (e.g., recruitment difficulties, adherence issues, logistical problems). This assessment will inform strategies for overcoming these barriers in a future, larger-scale RCT.
1 secondary outcome
Time to Normalization and Thyroid function Trends
Time frame: from enrollment to 24 week/6month follow up visit
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 23 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data from this pilot feasibility study will not be shared immediately due to the small sample size and the increased risk of participant re-identification. However, data sharing aligned with journal requirements will be considered upon publication of the study results. A detailed data sharing plan will be developed at that time, addressing ethical considerations and ensuring participant privacy while maximizing the scientific value of the data. This plan will outline the specific data to be shared (e.g., de-identified data, specific variables) and the process for requesting access.
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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.
Sharon Hyman, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ergocalciferol 50,000 IU and Methimazole in people with Graves Disease and Graves' Disease, run by Northwell Health at 1 site in United States.
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 8 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 23 Oct 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility Metrics: Recruitment Rate (time frame: through study completion, an average of 1 yea). The study lists 4 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 23 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.