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New treatment option for Graves Disease
Official title Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
ClinicalTrials.gov ID: NCT07369063
What this study is testing
What is Ergocalciferol 50,000 IU?
Ergocalciferol 50,000 IU is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for graves disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 17
You may be able to join if
- 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...
- Biochemical features include:
- Suppressed TSH \<0.1.
- Elevated T3
- Elevated Free T4
You likely can't join if
- 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...
- Allergy to vitamin D or methimazole
See the full eligibility criteria
- 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
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Hyde Park, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Hyde Park, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.