Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease

A vizsgálat adatai

Ki végzi

Northwell Health

Azonosító

NCT07369063

A regiszteradat frissítve

2026. október 23.

Eredeti leírás

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:A teljes eredeti leírásKevesebb

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.

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.

Bevonási feltételek: 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.

Kizáró feltételek: Current use of medications which are known to affect thyroid function or vitamin D metabolism such as thyroid hormone replacement, corticosteroids, anticonvulsants; Diagnosis of Hashitoxicosis or thyrotoxicosis (both TSH receptor antibody (TRAb) and thyroid-stimulating immunoglobulin (TSI) levels are negative); Conditions that affect vitamin D metabolism such as: malabsorption, chronic kidney or liver disease, nephrocalcinosis, hyperparathyroidism; Allergy to vitamin D or methimazole; Active or uncontrolled infections, other significant medical conditions deemed by the investigator to interfere with study participation or pose undue risk to the participant; Hypocalcemia, corrected calcium based on albumin <8.4 mg/dL; Hypercalcemia, corrected calcium based on albumin >10.5 mg/dL; Participants under the age of 9 years at the time of diagnosis; Initial hydroxy vitamin D levels >80 ng/mL; Pregnant participants.

ClinicalTrials.gov NCT07369063