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NCT00251316 · ClinicalTrials.gov registry record · Phase 2

Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer

A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 2
Development phase
34
Enrollment target

NCT00251316 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 34 participants.

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The verdict

NCT00251316, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

This study will examine the safety and effectiveness of using lithium, which has been used to enhance the effectiveness of high-dose 131I, with a single low dose (30 mCi) of 131I for thyroid ablation in patients with recently diagnosed papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid. Participants are randomly assigned to receive lithium capsules or placebo (look-alike capsules with no active ingredient). They follow a low-iodine diet for 2 weeks before starting treatment and are then admitted to the NIH Clinical Center for study and treatment for 11 days, during which they remain on the low-iodine diet. Blood samples are collected almost every day to analyze thyroid hormones, kidney and liver function, lithium concentrations and other tests.

Interventions

  • DRUG Placebo
  • DRUG Lithium Carbonate

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2005-11
Est. Completion 2011-12
Phase Phase 2

What the Registry Record Tells You About NCT00251316

The ClinicalTrials.gov registry entry for NCT00251316 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00251316 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00251316 about?

NCT00251316 is a clinical study titled "Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer". This study will examine the safety and effectiveness of using lithium, which has been used to enhance the effectiveness of high-dose 131I, with a single low dose (30 mCi) of 131I for thyroid ablation in patients with recently diagnosed papillary or follicular thyroid cancer who have had their thyroi...

What is the current status of trial NCT00251316?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2005-11. Estimated completion is 2011-12.

What interventions are being tested in trial NCT00251316?

The interventions under investigation include: Placebo (DRUG), Lithium Carbonate (DRUG).

Who is sponsoring clinical trial NCT00251316?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.