Trial Outcomes & Findings for Mechanistic Study of Subclinical Hypothyroidism In the Elderly (NCT NCT02399475)
NCT ID: NCT02399475
Last Updated: 2021-03-09
Results Overview
TSH area under the curve within 60 minutes of TRH stimulation when TSH is at goal
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
0, 5, 10, 15, 20, 30, and 60 min post TRH
Results posted on
2021-03-09
Participant Flow
Participant milestones
| Measure |
Levothyroxine First
Participants will start on the thyroid hormone Levothyroxine prior to crossing over to Liothyronine
Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L
Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L
Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment).
|
Liothyronine First
Participants will start on the thyroid hormone Liothyronine prior to crossing over to Levothyroxine
Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L
Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L
Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment).
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Levothyroxine First
Participants will start on the thyroid hormone Levothyroxine prior to crossing over to Liothyronine
Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L
Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L
Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment).
|
Liothyronine First
Participants will start on the thyroid hormone Liothyronine prior to crossing over to Levothyroxine
Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L
Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L
Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment).
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Mechanistic Study of Subclinical Hypothyroidism In the Elderly
Baseline characteristics by cohort
| Measure |
Levothyroxine First
n=6 Participants
Participants will start on the thyroid hormone Levothyroxine prior to crossing over to Liothyronine
Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L
Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L
Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment).
|
Liothyronine First
n=7 Participants
Participants will start on the thyroid hormone Liothyronine prior to crossing over to Levothyroxine
Levothyroxine: Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L
Liothyronine: Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L
Thyrotropin-Releasing Hormone: 200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment).
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77 years
STANDARD_DEVIATION 5 • n=39 Participants
|
77 years
STANDARD_DEVIATION 4 • n=41 Participants
|
77 years
STANDARD_DEVIATION 5 • n=35 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=39 Participants
|
7 participants
n=41 Participants
|
13 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 0, 5, 10, 15, 20, 30, and 60 min post TRHTSH area under the curve within 60 minutes of TRH stimulation when TSH is at goal
Outcome measures
| Measure |
Levothyroxine
n=13 Participants
While taking levothyroxine
|
Liothyronine
n=13 Participants
While taking liothyronine
|
|---|---|---|
|
TSH Area Under the Curve
|
267.8 μIU*min/mL
Standard Deviation 137.3
|
266.2 μIU*min/mL
Standard Deviation 140.2
|
PRIMARY outcome
Timeframe: Between 0 and 180 min after TRH stimulationThe maximum concentration of TSH after TRH stimulation when TSH is at goal
Outcome measures
| Measure |
Levothyroxine
n=13 Participants
While taking levothyroxine
|
Liothyronine
n=13 Participants
While taking liothyronine
|
|---|---|---|
|
TSH Max
|
5.5 mIU/L
Standard Deviation 3.0
|
5.4 mIU/L
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: An average of 7 months after initiating therapyFree thyroxine level when TSH level is at goal on therapy.
Outcome measures
| Measure |
Levothyroxine
n=13 Participants
While taking levothyroxine
|
Liothyronine
n=13 Participants
While taking liothyronine
|
|---|---|---|
|
Free T4 Level
|
1.65 ng/dL
Standard Deviation 0.11
|
0.46 ng/dL
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: An average of 7 monthsTotal triiodothyronine level when TSH is at goal on therapy
Outcome measures
| Measure |
Levothyroxine
n=13 Participants
While taking levothyroxine
|
Liothyronine
n=13 Participants
While taking liothyronine
|
|---|---|---|
|
Total T3 Level
|
1.12 ng/mL
Standard Deviation 0.24
|
1.98 ng/mL
Standard Deviation 0.51
|
Adverse Events
Levothyroxine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liothyronine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place