NCT01212965 is a Phase 1 clinical trial of Selenium in Lymphatic Malformations, sponsored by Medical College of Wisconsin.

Who is sponsoring NCT01212965?

NCT01212965 is sponsored by Medical College of Wisconsin.

What drugs are being tested in NCT01212965?

Interventions in NCT01212965: Selenium.

What condition does NCT01212965 study?

NCT01212965 studies Lymphatic Malformations.

Is NCT01212965 still recruiting?

NCT01212965 is currently terminated. Last updated 22 April 2013.

Last reviewed 2013-04-22 · How we verify

NCT01212965

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pilot Clinical Trial to Estimate the Safety and Efficacy of Selenium in the Treatment of Complicated Lymphatic Malformations in Adolescents and Young Adults

Terminated Phase 1 Last updated 22 April 2013

What this trial tests

Phase 1 trial testing Selenium in Lymphatic Malformations in 5 participants. Terminated before completion.

Timeline

1 September 2010

Primary endpoint
1 September 2011

1 November 2012

Quick facts

Lead sponsor	Medical College of Wisconsin
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	1 September 2010
Primary completion	1 September 2011
Estimated completion	1 November 2012
Sites	1 location across United States

Drugs / interventions tested

Selenium (SELENIUM) — full drug profile →

Conditions studied

Lymphatic Malformations — all drugs for Lymphatic Malformations →

Sponsor

Medical College of Wisconsin

Who can join

Adults 14 to 30, any sex, with Lymphatic Malformations. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Determine a preliminary rate to oral selenium in adolescents and young adults with symptomatic lymphatic malformations
Time frame: pretreatment and at 6 months
Disease will be assessed by volumetric MRI and patient quality of life assessments at 6 months of therapy and compared to pretreatment values.
Determine the safety of oral selenium in adolescents and young adults with symptomatic lymphatic malformations
Time frame: throughout duration of study

Sponsor's own description

The investigators propose a pilot trial to obtain preliminary information regarding the safety and response rate of patients with symptomatic lymphatic malformations treated with oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2 clinical trials. Hypotheses: * Selenium will be safe and efficacious in the treatment of adolescents and young adults with symptomatic lymphatic malformations * Disease response will correlate with serum levels of selenium and blood levels of antioxidants essential to selenium metabolism.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Selenium

Trials testing the same drug.

NCT07334197 — Effect of Melatonin on Left Ventricular Reverse Remodeling and Inflammation in Peripartum Cardiomyopathy · NA · not yet recruiting
NCT05672095 — Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer · Phase 1, PHASE2 · withdrawn
NCT06413043 — Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy · NA · not yet recruiting
NCT06951282 — Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study · Phase 1, PHASE2 · completed
NCT06362005 — The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus · Phase 4 · completed

Other recruiting trials for Lymphatic Malformations

Currently open trials in the same condition.

NCT05948943 — Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation. · Phase 2, PHASE3 · recruiting

Other Medical College of Wisconsin trials

Trials by the same sponsor.

NCT07260552 — Rapid Engagement for Solutions to Population and Outcomes Through Networked Dialogue for Coronary Heart Disease · not yet recruiting
NCT06795360 — Weight Changes After Incretin-mimetics · NA · not yet recruiting
NCT07228208 — Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes · NA · not yet recruiting
NCT07298460 — Stimulation-based Therapy to Improve Balance in DCM · Phase 1, PHASE2 · not yet recruiting
NCT07434544 — Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D) · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01212965 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
Last refreshed: 22 April 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01212965.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing