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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9-17
SponsorNorthwell Health

About this 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.

Eligibility criteria

Qualifiers

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.

Suppressed TSH <0.1.

Elevated T3

Elevated Free T4

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ergocalciferol 50,000 IU
  • Methimazole

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators