1,203
Participants
Start Date
October 31, 2006
Primary Completion Date
August 31, 2015
Study Completion Date
October 31, 2015
Levothyroxine
Coded study drug is thyroxine encapsulated in a gel capsule; matching placebo contains only cellulose. Color of capsule corresponds to mcg dose level (100mcg or 25 mcg). Subjects in subclinical hypothyroidism stratum are started on 1 capsule of 100 mcg per day; subjects in hypothyroxinemia stratum are started on 2 capsules of 25 mcg per day. Thyroxine dosing adjustments for both strata are determined centrally, using an algorithm, based on results of monthly TSH or free-T4 assays. Subjects take study medication until delivery.
Placebo for Levothyroxine
Columbia University, New York
University of Pittsburgh Magee Womens Hospital, Pittsburgh
University of North Carolina - Chapel Hill, Chapel Hill
University of Alabama - Birmingham, Birmingham
Ohio State University, Columbus
Case Western University, Cleveland
Wayne State University, Detroit
Northwestern University, Chicago
University of Texas - Southwest, Dallas
University of Texas-Houston, Houston
University of Texas Medical Branch - Galveston, Galveston
University of Utah Medical Center, Salt Lake City
Oregon Health & Sciences University, Portland
Brown University, Providence
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The George Washington University Biostatistics Center
OTHER