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Zinc, Chromium, Vitamin C, and Copper Combination Supplement for Prediabetes Progression

Study acronym: CHANGE
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 5, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  2. Phase: Not applicable to Phase 2v4
  3. Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study completion date: Mar 21, 2024 to Mar 31, 2025
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 9 more changesShow less
    • Primary completion date: Dec 30, 2022 to Dec 31, 2023
    • Start date changed from estimate of Oct 1, 2020 to Jun 23, 2021
    • Study completion date: Jun 21, 2023 to Mar 21, 2024
    • Interventions: Placebo (Other), Standard lifestyle counseling (Behavioral), Zinc, Chromium, Vitamin C, and Copper Supplementation (Dietary Supplement) to Placebo (Other), Standard healthy lifestyle intervention (Behavioral), Zinc, Chromium, Vitamin C, and Copper Supplementation (Dietary…
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: 4 to 9
    • Site details revised
    • Collaborator revised
    • Study description shortened, about 4 words
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Universitas Indonesia
94 trials monitored
See 3 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Currently, the incidence of diabetes mellitus is increasing worldwide. People with prediabetes have higher risk to develop diabetes mellitus type 2. Several studies have proven that Zinc and Chromium are minerals that contribute to decreasing the level of blood glucose and insulin resistance. In addition, vitamin C also contributes in decreasing Fasting Blood Glucose (FBG) and Hemoglobin A1c (HbA1c). However, the eficacy of a combined zinc, chromium, vitamin C, and copper (ZCC) in decreasing blood glucose in prediabetic people has never been performed. The primary objective of this study is to investigate the effect of a combination of ZCC supplementation with standard healthy lifestyle counseling in improving glucose profile \[Fasting Blood Glucose (FBG), 2-hour Oral Glucose Tolerance Test (OGTT), Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)\] from prediabetes to normal or reducing the risk of progression from prediabetes to Type 2-Diabetes Mellitus (T2DM) compared to placebo with standard healthy lifestyle intervention.
Trial Details
NCT Number NCT04511468
Lead Sponsor Universitas Indonesia
Collaborators: Blackmores Institute
Conditions
(from sponsor)		 PreDiabetes, Nutrition
Related terms Prediabetic State
Enrollment 670 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov