Trial · NCT02917863
Randomized Crossover Trial for the Evaluation of the Possible Effects in the Intestine of Two Different Pharmaceutical Forms of L - Thyroxine in Patients With Primary Acquired Hypothyroidism
NCT02917863, Phase 4, Unknown, Meyer Children's Hospital IRCCS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Crossover Trial for the Evaluation of the Possible Effects in the Intestine of Two Different Pharmaceutical Forms of L - Thyroxine in Patients With Primary Acquired Hypothyroidism. Trials, record NCT02917863. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02917863
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Crossover Trial for the Evaluation of the Possible Effects in the Intestine of Two Different Pharmaceutical Forms of L - Thyroxine in Patients With Primary Acquired Hypothyroidism
- NCT number
- NCT02917863
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 70 participants, estimated
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Conditions
- Hypothyroidism
- Interventions
- L-Thyroxine (tablet, per os), L-Thyroxine (oral drops, solution)
- First posted
- 2016-09-28
- Last updated
- 2016-09-28
- Other registries' IDs
- eudract:2015-001248-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effects on gut inflammation parameter (Calprotectin) | 0-6-12 months | Calculate the difference in gut inflammation parameter (calprotectin) among the two groups of patients at T6-T0 and T12-T6 |
| Primary | Effects on gut absorption parameters | 0-6-12 months | Calculate the difference in gut absorption parameters (Steatocrit) among the two groups of patients at T6-T0 and T12-T6 |
| Primary | Effects on gut inflammation parameter (Osteoprotegerin) | 0-6-12 months | Calculate the difference in gut inflammation parameter (osteoprotegerin) among the two groups of patients at T6-T0 and T12-T6 |
| Primary | Effects on gut inflammation parameter (S100-A12 protein) | 0-6-12 months | Calculate the difference in gut inflammation parameter (S100-A12 protein) among the two groups of patients at T6-T0 and T12-T6 |
| Secondary | Baseline gut microbiota characterization | baseline | Qualitative and quantitative (percentage) characterization of gut microbiota before the start of the therapy (T0) |
| Secondary | Difference in gut microbiota among hypothyroid and healthy subjects | baseline | Difference in gut microbiota among hypothyroid patients (T0) and healthy patients (data from Human Microbiome Project) |
| Secondary | Incidence of deamidated AGA | 6-12-24 months | Estimate the incidence of positive patients to deamidated AGA at T6, T12, T24 (follow-up) |
| Secondary | Baseline gut inflammation parameters | baseline | Evaluate gut inflammation (calprotectin, Osteoprotegerin and S100-A12 protein) parameters before the start of the therapy (T0) |
| Secondary | Baseline gut absorption parameters | baseline | Evaluate gut absorption (Steatocrit) parameters before the start of the therapy (T0) |
| Secondary | Difference in Shannon Index in the gut microbiota among liquid and solid L-Thyroxine formulations | 0-6-12 moths | Calculate the difference in Shannon Index (index of diversity) among the two groups of patients at T6-T0 and T12-T6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers7
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/NCT02917863
GET https://conductscience.org/api/trials/v1/NCT02917863/registered