Trial · NCT01367834
Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome
NCT01367834, Not applicable, Completed, Rebecca Knickmeyer Santelli, PhD; results first posted 2017-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome. Trials, record NCT01367834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01367834
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Growth Hormone on Early Brain Development in Girls With Turner Syndrome
- NCT number
- NCT01367834
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 17 participants, actual
- Lead sponsor
- Rebecca Knickmeyer Santelli, PhD
- Conditions
- Turner Syndrome
- Interventions
- somatotropin
- First posted
- 2011-06-07
- Last updated
- 2017-03-24
- Results first posted
- 2017-03-24
- Limitations and caveats
- Low scan success rate and subject drop out resulted in small sample size (5 GH treated, 1 control).
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Brain Volume | Change in volume from 12 months of age scan in 24 months of age scan | Percent change in total brain volume as determined by magnetic resonance imaging (MRI) |
| Secondary | Volume of Brain Lobes (Occipital) | Change in volume from 12 months of age scan in 24 months of age scan | Percent change in volumes of occipital lobes as determined by MRI. |
| Secondary | White Matter Tracts (SLF) | Change in FA from 12 months of age scan in 24 months of age scan | Change in the fractional anisotropy (FA) of white matter tracts using Diffusion Tensor Imaging (DTI); superior longitudinal fasciculus |
| Secondary | Volume of Brain Lobes (Central) | Change in volume from 12 months of age scan in 24 months of age scan | Percent change in volumes of central brain region (precentral gyrus, postcentral gyrus, rolandic operculum) as determined by MRI. |
| Secondary | Volume of Brain Lobes (Frontal) | Change in volume from 12 months of age scan in 24 months of age scan | Percent change in volumes of frontal lobes as determined by MRI. |
| Secondary | Volume of Brain Lobes (Temporal) | Change in volume from 12 months of age scan in 24 months of age scan | Percent change in volumes of temporal lobes as determined by MRI. |
| Secondary | Volume of Brain Lobes (Parietal) | Change in volume from 12 months of age scan in 24 months of age scan | Percent change in volumes of parietal lobes as determined by MRI. |
| Secondary | Volume of Brain Lobes (Limbic) | Change in volume from 12 months of age scan in 24 months of age scan | Percent change in volumes of parietal lobes as determined by MRI. |
| Secondary | Volume of Brain Lobes (Insular Cortex) | Change in volume from 12 months of age scan in 24 months of age scan | Percent change in volumes of parietal lobes as determined by MRI. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Brain Volume | Change in volume from 12 months of age scan in 24 months of age scan | Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol). | percentage change | MEAN |
| SECONDARY | Volume of Brain Lobes (Occipital) | Change in volume from 12 months of age scan in 24 months of age scan | Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol). | percentage change | MEAN |
| SECONDARY | White Matter Tracts (SLF) | Change in FA from 12 months of age scan in 24 months of age scan | Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol). | percentage change | MEAN |
| SECONDARY | Volume of Brain Lobes (Central) | Change in volume from 12 months of age scan in 24 months of age scan | Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol). | percentage change | MEAN |
| SECONDARY | Volume of Brain Lobes (Frontal) | Change in volume from 12 months of age scan in 24 months of age scan | Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol). | percentage change | MEAN |
| SECONDARY | Volume of Brain Lobes (Temporal) | Change in volume from 12 months of age scan in 24 months of age scan | Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol). | percentage change | MEAN |
| SECONDARY | Volume of Brain Lobes (Parietal) | Change in volume from 12 months of age scan in 24 months of age scan | Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol). | percentage change | MEAN |
| SECONDARY | Volume of Brain Lobes (Limbic) | Change in volume from 12 months of age scan in 24 months of age scan | Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol). | percentage change | MEAN |
| SECONDARY | Volume of Brain Lobes (Insular Cortex) | Change in volume from 12 months of age scan in 24 months of age scan | Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol). | percentage change | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Brain Volume | Growth Hormone | 18.22 | Standard Deviation 1.99 | percentage change | |
| Total Brain Volume | Control | 19.78 | Standard Deviation NA | percentage change | |
| Volume of Brain Lobes (Occipital) | Growth Hormone | 14.83 | Standard Deviation 2.21 | percentage change | |
| Volume of Brain Lobes (Occipital) | Control | 12.16 | Standard Deviation NA | percentage change | |
| White Matter Tracts (SLF) | Growth Hormone | 15.12 | Standard Deviation 5.01 | percentage change | |
| White Matter Tracts (SLF) | Control | 16.35 | Standard Deviation NA | percentage change | |
| Volume of Brain Lobes (Central) | Growth Hormone | 17.63 | Standard Deviation 2.13 | percentage change | |
| Volume of Brain Lobes (Central) | Control | 10.23 | Standard Deviation NA | percentage change | |
| Volume of Brain Lobes (Frontal) | Growth Hormone | 15.43 | Standard Deviation 1.84 | percentage change | |
| Volume of Brain Lobes (Frontal) | Control | 14.38 | Standard Deviation NA | percentage change |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Growth Hormone | 11 | |
| Overall Study | STARTED | Control | 6 | |
| Overall Study | COMPLETED | Growth Hormone | 9 | |
| Overall Study | COMPLETED | Control | 3 | |
| Overall Study | NOT COMPLETED | Growth Hormone | 2 | |
| Overall Study | NOT COMPLETED | Control | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Growth Hormone | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Growth Hormone | 0 | 11 |
| Total, other adverse events | Control | 0 | 6 |
| Total, serious adverse events | Growth Hormone | 0 | 11 |
| Total, serious adverse events | Control | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Growth Hormone vs Control: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01367834
GET https://conductscience.org/api/trials/v1/NCT01367834/registered