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Trial · NCT01942694

Registered outcomes27

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime to Development of DiabetesApproximately 48 months
New-onset diabetes was based on annual glycemic testing of fasting plasma glucose, glycated hemoglobin, and 2-hour post-load plasma glucose and semiannual testing of fasting plasma glucose and glycated hemoglobin. If two or three of the glycemic measures met the 2010 ADA thresholds for diabetes, the participant was considered to have met the diabetes outcome. When only the measure for fasting plasma glucose or glycated hemoglobin met the threshold, confirmatory testing was performed for the positive measure within 8 weeks. If only the measure for 2-hour post-load plasma glucose met the threshold, then a 75-g oral glucose tolerance test to reassess all three glycemic measures was repeated. If the repeat measure was positive or both fasting plasma glucose and glycated hemoglobin were positive (in the case of a repeat oral glucose tolerance test), than the participant was considered to have met the diabetes outcome.
SecondaryVariability of Response to Vitamin D Supplementation by Baseline Characteristic: 25OHD ConcentrationApproximately 48 months
SecondaryVariability of Response to Vitamin D Supplementation by Baseline Characteristic: Race (as a Proxy for Skin Pigmentation)Approximately 48 months
Race and ethnic group were reporting by the participant. The category "other" includes American Indian or Alaska Native; Native Hawaiian or other Pacific Islander; and other race. Ethnic group includes any race.
SecondaryVariability of Response to Vitamin D Supplementation by Baseline Characteristic: Pre-diabetes Criteria (Two vs. Three Criteria)Approximately 48 months
Participants met at least two of three glycemic criteria for prediabetes: fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mmol per liter); plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mmol per liter) (impaired glucose tolerance); and glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mmol per mole).
SecondaryVariability of Response to Vitamin D Supplementation by Baseline Characteristic: BMIApproximately 48 months
SecondaryVariability of Response to Vitamin D Supplementation by Baseline Characteristic: Waist CircumferenceApproximately 48 months
SecondaryVariability of Response to Vitamin D Supplementation by Baseline Characteristic: AgeApproximately 48 months
SecondaryVariability of Response to Vitamin D Supplementation by Baseline Characteristic: Geographic Location (as a Proxy for Sun Exposure)Approximately 48 months
SecondaryVariability of Response to Vitamin D Supplementation by Baseline Characteristic: Calcium Intake From SupplementsApproximately 48 months
SecondaryBlood Plasma 25OHD Concentration.Approximately 48 months
SecondaryNumber of Participants With Adverse Events.Approximately 48 months
SecondaryChange in Blood Pressure as a Continuous Variable.Approximately 48 months
SecondaryNumber of Participants Who Discontinue Study Pills.Approximately 48 months
SecondaryChange in FPG as a Continuous Variable.Every 12 months for approximately 48 months
SecondaryChange in 2hPG as a Continuous Variable.Every 12 months for approximately 48 months.
SecondaryChange in HbA1c as a Continuous Variable.Every 6 months for approximately 48 months
SecondaryMeasurement of Insulin Resistance (Derived From the OGTT).Every 12 months for approximately 48 months
SecondaryMeasurement of Beta Cell Secretion (Derived From the OGTT)Every 12 months for approximately 48 months
SecondaryIdentification of Characteristics Associated With the Variability in Achieved 25OHD Concentration.Every 12 months for approximately 48 months
OtherVariability of Response to Vitamin D Supplementation by Baseline Characteristic: SexApproximately 48 months.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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