Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540469
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Iodine Supplementation in Graves Hyperthyroidism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Optimal Iodine Supplementation in Anti-thyroid Drug Therapy for Graves Hyperthyroidism a Prospective Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In China the morbidity of thyroid diseases is high and the harm is serious Iodine is closely related to thyroid diseases It should be paid attention to guide patients to supplement iodine scientifically Thyroid iodine uptake in hyperthyroidism patients is enhanced and patients are generally advised to limit iodine intake in clinical practice However recent studies suggest that there is no definite conclusion on whether patients with hyperthyroidism should strictly limit iodine intake The purpose of this study is to establish a national multi-center iodine intervention cohort for patients with Graves hyperthyroidism identify the effects of different iodine intake on hyperthyroidism and establish iodine intervention program for hyperthyroidism This study is a multicenter prospective open-level randomized controlled parallel group clinical trial with a total sample size of 315 cases a total of 3 participating units each of which completed 105 cases All subjects meeting the inclusion criteria were completely randomized in each center according to the random procedure with a probability of 111 ① Iodine Supplementation in Whole Course of Treatment with ATDs ② Iodine Supplementation During Maintenance Treatment with ATDs ③ Iodine Restriction in Whole Course of Treatment with ATDs Information was collected before ATD treatment at 3 months 6 months 12 months 18 months withdrawal 6 months and 12 months after ATDs withdrawal The primary purpose of this study is to analyze the difference in remission rate of hyperthyroidism between different iodine nutritional interventions At the same time the differences of duration from initiation to withdrawal of ATDs duration from initiation of ATDs to thyroid function including serum FT3 FT4 and TSH normalization duration from initiation of ATDs to serum FT3 and FT4 normalization quality of life QOL in patients with Graves hyperthyroidism adverse effects rate of ATDs treatment duration from initiation of ATDs to serum negative TRAb is first measured were observed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None