Trial · NCT02168660
Correction of Vitamin D Levels and Its Effect on Insulin Resistance and Weight Gain in Obese Youth
NCT02168660, Phase 2, Completed, Perrin C White, MD; results first posted 2019-12-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Correction of Vitamin D Levels and Its Effect on Insulin Resistance and Weight Gain in Obese Youth. Trials, record NCT02168660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02168660
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Correction of Vitamin D Levels and Its Effect on Insulin Resistance and Weight Gain in Obese Youth
- NCT number
- NCT02168660
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Perrin C White, MD
- Conditions
- Obesity, Insulin Resistance, Vitamin D Deficiency
- Interventions
- Vitamin D3
- First posted
- 2014-06-20
- Last updated
- 2019-12-09
- Results first posted
- 2019-12-09
- Limitations and caveats
- Because of poor subject retention, there were insufficient outcome data to allow hypothesis testing.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in HOMA-IR | 4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached). | Change in HOMA-IR from initial visit to end-of-study visit; i.e., the value at the later time point minus the value at the earlier time point. HOMA-IR= Fasting insulin (mIU/ml) x Fasting glucose (mg/dl) / 405. |
| Secondary | Time to Normalization of Vit D Level Versus BMI Z Score | 1 to 12 months | The time required to reach a normal Vitamin D level (\> 30) versus BMI Z score at each vitamin D3 dose; OR vitamin D level at 6 weeks versus BMI Z score at each starting vitamin D3 dose. |
| Secondary | Change in BMI Z-score | 4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached). | The change in BMI z-score from baseline to end-of-study visit; i.e., the value at the later time point minus the value at the earlier time point. The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in HOMA-IR | 4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached). | Beginning and ending anthropometric data were available within the specified time limits on 61 subjects and 25-hydroxyvitamin D3 (25-OHD) levels on 45. Corresponding insulin and glucose data (allowing calculation of HOMA-IR) were available on only 26 subjects, mainly because many 25-OHD levels were obtained when subjects were not fasting. | HOMA-IR score | MEDIAN |
| SECONDARY | Time to Normalization of Vit D Level Versus BMI Z Score | 1 to 12 months | Timing of sample collections was too irregular to permit analysis. | ||
| SECONDARY | Change in BMI Z-score | 4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached). | z-score | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in HOMA-IR | Control Group | 0 | Inter-Quartile Range -1.8 to 1.4 | HOMA-IR score | |
| Change in HOMA-IR | Low-Normal Group | -1.5 | Inter-Quartile Range -3.9 to 0.9 | HOMA-IR score | |
| Change in HOMA-IR | High-Normal Group | -1.7 | Inter-Quartile Range -4.3 to -0.3 | HOMA-IR score | |
| Change in BMI Z-score | Control Group | 0.03 | Inter-Quartile Range -0.04 to 0.07 | z-score | |
| Change in BMI Z-score | Low-Normal Group | -0.07 | Inter-Quartile Range -0.11 to -0.03 | z-score | |
| Change in BMI Z-score | High-Normal Group | -0.03 | Inter-Quartile Range -0.12 to 0.0 | z-score |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Group | 38 | |
| Overall Study | STARTED | Low-Normal Group | 35 | |
| Overall Study | STARTED | High-Normal Group | 36 | |
| Overall Study | COMPLETED | Control Group | 22 | |
| Overall Study | COMPLETED | Low-Normal Group | 18 | |
| Overall Study | COMPLETED | High-Normal Group | 21 | |
| Overall Study | NOT COMPLETED | Control Group | 16 | |
| Overall Study | NOT COMPLETED | Low-Normal Group | 17 | |
| Overall Study | NOT COMPLETED | High-Normal Group | 15 |
Source ClinicalTrials.gov
Adverse events3
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 | abdominal pain | Gastrointestinal disorders | Control Group | 0 | 22 | |
| other | abdominal pain | Gastrointestinal disorders | Low-Normal Group | 1 | 18 | 1 |
| other | abdominal pain | Gastrointestinal disorders | High-Normal Group | 0 | 21 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Group | 0 | 22 |
| Total, all-cause mortality | Low-Normal Group | 0 | 18 |
| Total, all-cause mortality | High-Normal Group | 0 | 21 |
| Total, other adverse events | Control Group | 0 | 22 |
| Total, other adverse events | Low-Normal Group | 1 | 18 |
| Total, other adverse events | High-Normal Group | 0 | 21 |
| Total, serious adverse events | Control Group | 0 | 22 |
| Total, serious adverse events | Low-Normal Group | 0 | 18 |
| Total, serious adverse events | High-Normal Group | 0 | 21 |
Source ClinicalTrials.gov
Papers9
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/NCT02168660
GET https://conductscience.org/api/trials/v1/NCT02168660/registered