Trial · NCT01576705
Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
NCT01576705, Phase 3, Completed, Institut Jerome Lejeune; results first posted 2020-05-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children. Trials, record NCT01576705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01576705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children
- NCT number
- NCT01576705
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 175 participants, actual
- Lead sponsor
- Institut Jerome Lejeune
- Conditions
- Down Syndrome
- Interventions
- thyroid hormone and folinic acid
- First posted
- 2012-04-12
- Last updated
- 2020-05-13
- Results first posted
- 2020-05-13
- Limitations and caveats
- The initial protocol planned for 256 patients, however due to difficulties in recruiting patients, the sample size was subsequently reduced to 175 patients, to obtain 140 evaluable patients.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | GMDS (Griffiths Mental Development Scale) | 12 months | GMDS for testing and estimate babies psychomotor development from birth to 2 years trough six subscales : Locomotor, Personal-social, Hearing and language, Eye-Hand coordination, Performance.Sub- and General Quotients (GDQ) standard score are based on a mean of 100 and a standard deviation of 16. For children with delayed development, which is the case for children with Down Syndrome, Quotient tables could be not used because sub- and General quotient floors at 50. For each subscale, a raw score was derived from the contributing items. Total raw score was obtained by adding subscale raw scores. Sum of all subscale raw scores was converted into a development age using correspondence table. Subscale and global development quotients were computed by dividing the development age by the chronological age multiplied by 100. For preterm infants, chronological age was corrected taking into account the gestational term. Higher QD's scores show a better psychomotor development outcome |
| Secondary | BL (Brunet Lezine Revised Scale) | 12 months | BL includes 4 subscales : Locomotor, Coordination, Language, Sociability. Subscale and global developpemental quotients were computed by dividing the developpemental age by the chronological age multiplied by 100. This kind of formula do not give a min-max outcome. Higher QD's scores show a better psychomotor developpement outcome. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | GMDS (Griffiths Mental Development Scale) | 12 months | The main analysis of the primary efficacy endpoint is the adjusted change from baseline in GDQ derived from the Griffith Mental Development Scales (GMDS) at 12 months analysed by ANCOVA adjusted for covariates. Expected Outcome : six points difference in GDQ between any of the three treatment group compared to placebo at 12 months from baseline. | developpement quotient | MEAN |
| SECONDARY | BL (Brunet Lezine Revised Scale) | 12 months | The main analysis of the secondary efficacy endpoint of the adjusted change from baseline in the BL-R GDQ at 12 months, analysed by ANCOVA adjusted for covariates, is presented in the mITT population. | developpement quotient | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| GMDS (Griffiths Mental Development Scale) | Thyroxin + Folinic Acid | 51.96 | Standard Deviation 7.88 | developpement quotient | |
| GMDS (Griffiths Mental Development Scale) | Thyroxin+Folinic Acid Placebo | 51.27 | Standard Deviation 6.48 | developpement quotient | |
| GMDS (Griffiths Mental Development Scale) | Thyroxin Placebo+ Folinic Acid | 51.66 | Standard Deviation 6.37 | developpement quotient | |
| GMDS (Griffiths Mental Development Scale) | Thyroxin Placebo+ Folinic Acid Placebo | 51.67 | Standard Deviation 8.29 | developpement quotient | |
| BL (Brunet Lezine Revised Scale) | Thyroxin + Folinic Acid | 51.18 | Standard Deviation 6.98 | developpement quotient | |
| BL (Brunet Lezine Revised Scale) | Thyroxin+Folinic Acid Placebo | 50.64 | Standard Deviation 7.25 | developpement quotient | |
| BL (Brunet Lezine Revised Scale) | Thyroxin Placebo+ Folinic Acid | 51.24 | Standard Deviation 6.46 | developpement quotient | |
| BL (Brunet Lezine Revised Scale) | Thyroxin Placebo+ Folinic Acid Placebo | 51.36 | Standard Deviation 8.27 | developpement quotient |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Thyroxin + Folinic Acid | 43 | |
| Overall Study | STARTED | Thyroxin+Folinic Acid Placebo | 45 | |
| Overall Study | STARTED | Thyroxin Placebo+ Folinic Acid | 43 | |
| Overall Study | STARTED | Thyroxin Placebo+ Folinic Acid Placebo | 44 | |
| Overall Study | COMPLETED | Thyroxin + Folinic Acid | 40 | |
| Overall Study | COMPLETED | Thyroxin+Folinic Acid Placebo | 37 | |
| Overall Study | COMPLETED | Thyroxin Placebo+ Folinic Acid | 38 | |
| Overall Study | COMPLETED | Thyroxin Placebo+ Folinic Acid Placebo | 41 | |
| Overall Study | NOT COMPLETED | Thyroxin + Folinic Acid | 3 | |
| Overall Study | NOT COMPLETED | Thyroxin+Folinic Acid Placebo | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events52
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 | Endocrine disorders | Endocrine disorders | Thyroxin+Folinic Acid Placebo | 0 | 44 | 0 |
| other | Endocrine disorders | Endocrine disorders | Thyroxin + Folinic Acid | 0 | 43 | 0 |
| other | Endocrine disorders | Endocrine disorders | Thyroxin Placebo+ Folinic Acid | 5 | 43 | 5 |
| other | Endocrine disorders | Endocrine disorders | Thyroxin Placebo+ Folinic Acid Placebo | 0 | 44 | 0 |
| other | Neoplasms begnin, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Thyroxin+Folinic Acid Placebo | 0 | 44 | 0 |
| other | Neoplasms begnin, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Thyroxin + Folinic Acid | 0 | 43 | 0 |
| other | Neoplasms begnin, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Thyroxin Placebo+ Folinic Acid | 1 | 43 | 1 |
| other | Neoplasms begnin, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Thyroxin Placebo+ Folinic Acid Placebo | 0 | 44 | 0 |
| other | Nervous system disorders | Nervous system disorders | Thyroxin+Folinic Acid Placebo | 0 | 44 | 0 |
| other | Nervous system disorders | Nervous system disorders | Thyroxin + Folinic Acid | 0 | 43 | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thyroxin+Folinic Acid Placebo | 0 | 44 |
| Total, all-cause mortality | Thyroxin + Folinic Acid | 1 | 43 |
| Total, all-cause mortality | Thyroxin Placebo+ Folinic Acid | 0 | 43 |
| Total, all-cause mortality | Thyroxin Placebo+ Folinic Acid Placebo | 0 | 44 |
| Total, other adverse events | Thyroxin+Folinic Acid Placebo | 0 | 44 |
| Total, other adverse events | Thyroxin + Folinic Acid | 0 | 43 |
| Total, other adverse events | Thyroxin Placebo+ Folinic Acid | 7 | 43 |
| Total, other adverse events | Thyroxin Placebo+ Folinic Acid Placebo | 0 | 44 |
| Total, serious adverse events | Thyroxin+Folinic Acid Placebo | 9 | 44 |
| Total, serious adverse events | Thyroxin + Folinic Acid | 8 | 43 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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.
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/NCT01576705
GET https://conductscience.org/api/trials/v1/NCT01576705/events?page=2