Trial · NCT00565864
Neurocognitive and Metabolic Effects of Mild Hypothyroidism
NCT00565864, Phase 4, Completed, Oregon Health and Science University; results first posted 2018-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Neurocognitive and Metabolic Effects of Mild Hypothyroidism. Trials, record NCT00565864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00565864
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neurocognitive and Metabolic Effects of Mild Hypothyroidism
- NCT number
- NCT00565864
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 173 participants, actual
- Lead sponsor
- Oregon Health and Science University
- Conditions
- Hypothyroidism
- Interventions
- L-thyroxine (L-T4)
- First posted
- 2007-11-30
- Last updated
- 2018-08-22
- Results first posted
- 2018-08-22
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Executive Function | 24 weeks | Iowa Gambling Task Net-5. Four decks of cards are shown face down on a computer screen. The subject chooses cards from any deck, resulting in the gain or loss of money. The subject is unaware that 2 decks are advantageous (small gains, smaller losses), while 2 are disadvantageous (large gains, larger losses). The subject's choices are classified as advantageous (X) or disadvantageous (Y), with a net score of X-Y, over 5 trials of 100 cards each. The outcome reported here is the score on the fifth trial, which is generally the best trial due to practice effects. The minimum score is -20 and the maximum score is +20. Higher scores indicate a better outcome. |
| Primary | Resting Energy Expenditure | 24 weeks | Measurement of resting energy expenditure (REE) by indirect calorimetry, corrected for lean body mass. Indirect calorimetry is performed at 21.1° C after the participant has fasted for 12h and abstains from significant physical activity for 24h. The indirect calorimeter (VMax Encore 29N Indirect Calorimeter, SensorMedics Viasys Healthcare, Yorba Linda, CA) samples expired air and analyzes it for the volume of oxygen consumed (VO2) and the volume of carbon dioxide produced (VCO2) each minute for 30mins. REE is then calculated using the modified Weir equation. Minimum REE is 23 kcal/kg LBM/day and maximum REE is 39 kcal/kg LBM/day. Within that range, higher levels are considered better for the purposes of this study. |
| Other | Quality of Life by SF-36 Survey | 24 weeks | Short Form Survey (SF-36) mental component summary, which combines results from mental component subscales of the SF-36. The SF-36 health survey (SF-36) is a questionnaire about general health and well-being (127). It consists of 8 subscales (bodily pain, general health, mental health, physical functioning, vitality, role physical, social functioning, role emotional) and two summary scales (Mental Component and Physical Component Summaries). The mental component summary is a weighted average of the 8 subscales, with more weight to role emotional and mental health subscales. Minimum score for the SF-36 mental component summary is 14. Maximum score is 50. Higher scores on the SF-36 summary scales and subscales reflect better health status and well-being. |
| Other | Mood | 24 weeks | Profile of Mood States (POMS) fatigue subscale. The POMS consists of survey questions that cover 6 subscales: anxiety, confusion, depression-dejection, fatigue, tension, and vigor. Each subscale score is calculated from weighted averages of individual questions related to the subject's perception of fatigue. Minimum score for the fatigue subscale is 0. Maximum score is 30. Higher scores on the POMS fatigue subscale are worse. |
| Other | Working Memory | 24 weeks | 3-Back correct on target. The N-Back test consists of three conditions of increasing load on working memory, the 1-Back, 2-Back and 3-Back. In the 1-Back, letters are presented one at a time on a computer screen for 2 sec (1 sec interstimulus interval) during which the subject responds with a key press if a particular letter appears that had appeared on the previous screen. In the 2-Back, the subject must hold in mind letters and respond when s/he sees a letter that was previously presented two screens back. In the 3-Back, the subject responds when s'he sees a letter that was presented three screens back. N-back test measures the updating and storage functions of working memory. The test is scored as the number of targets correctly identified in each condition. The outcome of interest here is the number correct on target during the 3-Back, which is the most difficult of the three conditions. Minimum score is 0. Maximum score is 16. Higher scores are better. |
| Other | Declarative Memory | 24 weeks | Paragraph Recall - 30 min. Subjects were read a brief story and verbally recalled it immediately and after 30 minutes. The score was the total number of story elements recalled at 30 minutes. Minimum score is 0; Maximum score is 20. Higher scores are better. |
| Other | Motor Learning | 24 weeks | Pursuit Rotor Trial 4. This test is performed on a photoelectric pursuit Rotor (Model 30014, Lafayette Instrument Company, Lafayette, IN). Subjects hold a photosensitive wand to maintain contact with a 2 cm. light disk rotating on a variable speed turntable. An initial block of 4 trials is administered at 15, 30, 45, and 60 revolutions per minute. The speed at which the subject remains on-target is the rate at which remaining trials are performed. Three blocks of eight 20-second trials are then administered, with a 20-sec rest after each trial, and a 60-sec rest period after 4 trials. This sequence is repeated after a retention interval of 30 minutes. The measure of interest here is the time the wand maintains on target during the final trial. Minimum score is 0; maximum score is 80 seconds. Higher numbers are better. |
| Other | Total Energy Expenditure | 24 weeks | Total energy expenditure (TEE) measured by isotopic doubly labelled water (DLW) technique, corrected for lean body mass. A urine sample is collected and analyzed for background enrichment of deuterium and 18-O. The subject then drinks a dose of doubly labeled water at 1.7 gm per kg body weight, Samples are collected 2, 3 and 4 hours and seven days following the DLW dose to determine whole body equilibrium. Samples are measured as a ratio of deuterium to hydrogen in hydrogen gas and 18-O/ 16-O in CO2 using a Europa 20/20 Isotope Ratio Mass Spectrometer (Metabolic Solutions, Inc., Nashau, NH). CO2 production is then used to calculate TEE by Weir's equation. Minimum value is 36 kcal/kg LBM/day. Maximum value is 74 kcal/kg LBM/day. Within this range, higher values are considered to be better for the purposes of this study. |
| Other | Thermic Effect of Food | 24 weeks | Thermic effect of food (TEF)is a measurement of energy expenditure over 5 hours following consumption of a standard test meal by indirect calorimetry. Each subject consumes a liquid mixed meal (Ensure, Ross Laboratories, 14% protein, 31.5% fat, and 54.5% carbohydrate) over 5 minutes and sampling for O2 and CO2 is then done by indirect calorimetry for the last 6 min of every 0.5 h for 5 h. For each metabolic measurement the respiratory exchange ratio (respiratory quotient or RQ = VCO2/VO2) is calculated and results converted to kilocalories by the Weir equation. Minimum value is 5 kcal/day. Maximum value is 730 kcal/day. Within this range, higher values are considered to be better for the purposes of this study. |
| Other | Physical Activity Energy Expenditure | 24 weeks | Physical activity energy expenditure (PAEE) by accelerometry, corrected for lean body mass. The Actical activity monitoring device (Mini Mitter Co Inc, Bend, OR) utilizes a multidirectional accelerometer to monitor the occurrence and intensity of motion, or epoch (137). The Actical device measures 3 cm by 3 cm, weighs 17.0 grams, and is securely attached to a waistband and placed around the waist. The device is worn for 7 days. Data are downloaded from the accelerometer using an ActiReader and converted into total activity counts, average activity (counts per minute), time interval duration (minutes), activity ranges during sedentary, light, moderate, and vigorous activity, and accumulated time within each activity range (minutes). These data are then converted to PAEE by proprietary algorithms. Minimum value is 3 kcal/kg LBM/day. Maximum value is 40 kcal/kg LBM/day. Higher values are better. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Executive Function | 24 weeks | units on a scale | MEAN | |
| PRIMARY | Resting Energy Expenditure | 24 weeks | kcal/kg LBM/day | MEAN | |
| OTHER_PRE_SPECIFIED | Quality of Life by SF-36 Survey | 24 weeks | units on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Mood | 24 weeks | units on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Working Memory | 24 weeks | units on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Declarative Memory | 24 weeks | units on a scale | MEAN | |
| OTHER_PRE_SPECIFIED | Motor Learning | 24 weeks | seconds | MEAN | |
| OTHER_PRE_SPECIFIED | Total Energy Expenditure | 24 weeks | The number of participants analyzed is less than the total number of participants due to a nationwide shortage of doubly labelled water during the study. This meant that not all subjects entered into the study were able to receive the doubly labelled water. | kcal/kg LBM/day | MEAN |
| OTHER_PRE_SPECIFIED | Thermic Effect of Food | 24 weeks | The number of subjects who underwent measurement of thermic effect of food was less than the total number of subjects in the study due to scheduling constraints. TEF measurements take over 5 hours, and some subjects did not have sufficient time to participate in this part of the study, but were still able to conduct the other activities. | kcal/day | MEAN |
| OTHER_PRE_SPECIFIED | Physical Activity Energy Expenditure | 24 weeks | A few subjects did not have data collected due to a technical problem with downloading their data from the Actical device. | kcal/kg LBM/day | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Executive Function | Arm 1 | 7.9 | Standard Error 1.6 | units on a scale | |
| Executive Function | Arm 2 | 7.5 | Standard Error 1.5 | units on a scale | |
| Executive Function | Arm 3 | 8.8 | Standard Error 1.6 | units on a scale | |
| Resting Energy Expenditure | Arm 1 | 30.3 | Standard Error 0.4 | kcal/kg LBM/day | |
| Resting Energy Expenditure | Arm 2 | 30.0 | Standard Error 0.4 | kcal/kg LBM/day | |
| Resting Energy Expenditure | Arm 3 | 30.0 | Standard Error 0.5 | kcal/kg LBM/day | |
| Quality of Life by SF-36 Survey | Arm 1 | 41.0 | Standard Error 0.9 | units on a scale | |
| Quality of Life by SF-36 Survey | Arm 2 | 39.8 | Standard Error 1.1 | units on a scale | |
| Quality of Life by SF-36 Survey | Arm 3 | 39.4 | Standard Error 1.0 | units on a scale | |
| Mood | Arm 1 | 7.4 | Standard Error 0.8 | units on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 58 | |
| Overall Study | STARTED | Arm 2 | 59 | |
| Overall Study | STARTED | Arm 3 | 56 | |
| Overall Study | COMPLETED | Arm 1 | 46 | |
| Overall Study | COMPLETED | Arm 2 | 47 | |
| Overall Study | COMPLETED | Arm 3 | 45 | |
| Overall Study | NOT COMPLETED | Arm 1 | 12 | |
| Overall Study | NOT COMPLETED | Arm 2 | 12 | |
| Overall Study | NOT COMPLETED | Arm 3 | 11 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | medication error | Product Issues | Arm 1 | 2 | 46 | 2 |
| other | medication error | Product Issues | Arm 2 | 1 | 47 | 1 |
| other | medication error | Product Issues | Arm 3 | 2 | 45 | 2 |
| other | symptoms | Endocrine disorders | Arm 1 | 0 | 46 | 0 |
| other | symptoms | Endocrine disorders | Arm 2 | 1 | 47 | 1 |
| other | symptoms | Endocrine disorders | Arm 3 | 1 | 45 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | ||
| Total, all-cause mortality | Arm 2 | ||
| Total, all-cause mortality | Arm 3 | ||
| Total, other adverse events | Arm 1 | 2 | 46 |
| Total, other adverse events | Arm 2 | 2 | 47 |
| Total, other adverse events | Arm 3 | 3 | 45 |
| Total, serious adverse events | Arm 1 | 0 | 46 |
| Total, serious adverse events | Arm 2 | 0 | 47 |
| Total, serious adverse events | Arm 3 | 0 | 45 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Iowa Gambling Lite | Primary outcome | ConductCognition |
| 1-Back Task | Other outcome | ConductCognition |
| 2-Back Task | Other outcome | ConductCognition |
| Pursuit Tracking Test | Other outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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