Trial · NCT01206478
Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age
NCT01206478, Phase 2, Completed, Ann Davis, PhD, MPH, ABPP; results first posted 2016-08-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age. Trials, record NCT01206478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01206478
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Amitriptyline for Chronic Oral Food Refusal in Children 9 Months to 8 Years of Age
- NCT number
- NCT01206478
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- Ann Davis, PhD, MPH, ABPP
- Conditions
- Chronic Oral Food Refusal
- Interventions
- Amitriptyline, Placebo, Megestrol
- First posted
- 2010-09-21
- Last updated
- 2016-08-15
- Results first posted
- 2016-08-15
- Limitations and caveats
Major weakness was our small sample size, which was directly due to problems with recruitment, which occurred uniformly across sites. The primary reason for refusal was that parents did not want to be randomly assigned to the amitriptyline/placebo.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | % Calories Taken Orally | baseline, 24 weeks | Percent Kilocalories (kcal) Obtained Orally. This measure was obtained using the 24 hour food recall, a standardized five-pass method developed by the US Department of Agriculture for use in national dietary surveillance. This measure has been widely used in several large trials and data suggest it is the most valid and reliable method of dietary assessment for children (20). The data were collected at week 0, week 10, and week 24 using standardized probes by highly trained research staff, and parents were presented with paper food models and measuring devices prior to interviews to reference during the recall. Recalls were analyzed with the Nutritional Data System for Research, version 2005; University of Minnesota, Minneapolis, MN. |
| Secondary | Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores | baseline, 24 weeks | Non-communicating Children's Pain Checklist - Revised (NCCPC-R) used to measure outcome. The NCCPC-R is a 30 item measure intended to assess pain in children who are unable to speak because of cognitive or physical impairments. There are 7 sub-scales including vocal, social, facial, activity, body/limbs, physiological, and eating/sleeping. Each question has a potential score of 0 to 3. Scores are totaled for each sub-scale. Sub-scale scores are then added together for the Total Score. Total Scores can range from 0 to 90. The higher the score, the higher level of pain indicated by the child. This measure was completed by parents at week 0, week 10, and week 24. |
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 | % Calories Taken Orally | baseline, 24 weeks | change in percent kcal obtained orally | MEAN | |
| SECONDARY | Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores | baseline, 24 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| % Calories Taken Orally | Amitriptyline, Megestrol | 68.62 | Standard Deviation 17.29 | change in percent kcal obtained orally | |
| % Calories Taken Orally | Placebo, Megestrol | 76.89 | Standard Deviation 15.68 | change in percent kcal obtained orally | |
| Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores | Amitriptyline, Megestrol | -2.5 | Standard Deviation 19.85 | units on a scale | |
| Change in Non-communicating Children's Pain Checklist - Revised (NCCPC-R) Scores | Placebo, Megestrol | -6.86 | Standard Deviation 8.65 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amitriptyline, Megestrol | 9 | |
| Overall Study | STARTED | Placebo, Megestrol | 12 | |
| Overall Study | COMPLETED | Amitriptyline, Megestrol | 7 | |
| Overall Study | COMPLETED | Placebo, Megestrol | 7 | |
| Overall Study | NOT COMPLETED | Amitriptyline, Megestrol | 2 | |
| Overall Study | NOT COMPLETED | Placebo, Megestrol | 5 |
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 | Amitriptyline, Megestrol | ||
| Total, all-cause mortality | Placebo, Megestrol | ||
| Total, other adverse events | Amitriptyline, Megestrol | 0 | 9 |
| Total, other adverse events | Placebo, Megestrol | 0 | 12 |
| Total, serious adverse events | Amitriptyline, Megestrol | 0 | 9 |
| Total, serious adverse events | Placebo, Megestrol | 0 | 12 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21HD066629 | "A randomized controlled trial of amitriptyline for chronic oral food refusal" | DAVIS, ANN M | UNIVERSITY OF KANSAS MEDICAL CENTER | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2010 to 2011 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Amitriptyline, Megestrol vs Placebo, Megestrol: 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/NCT01206478
GET https://conductscience.org/api/trials/v1/NCT01206478/registered