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TerminatedNCT03356873VICOXUpdated Mar 15, 2023

Impact of Correction of Vitamin D Deficiency in Oxidative Stress in Patients With Prediabetes (VICOX)

An interventional study of Vitamin D and Placebo in Vitamin D Deficiency, Glucose Intolerance and Oxidative Stress, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Terminated at 1 site in Mexico. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-15.

Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Not applicable, Interventional, and Treatment

Why this study was terminated
COVID19
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 154 studies testing Vitamin D in Vitamin D Deficiency — 15 open to participants now, 16 under way, none of them phase 3. Vitamin D · Vitamin D Deficiency.

Enrollment
111th of 153
31 · median 75
Started
2017
with 10 others
No phase
87 of 154
12 open now
Registered
94th of 154
by date

Among the 154 studies testing Vitamin D in Vitamin D Deficiency, this one is the 111th largest by enrollment of the 153 interventional ones that give a count, is one of 11 that started in 2017, is one of 87 with no phase, and was the 94th registered.

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

Browse Vitamin D Deficiency studies →

Open to participants now

15 of the 154 studies testing Vitamin D in Vitamin D Deficiency are open now, in 8 countries. Recruiting first, the newest first:

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By country, each count listing its studies:

All 15 open studies →

About Vitamin D

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 37 Vitamin D Deficiency studies recruiting now, 16 (43%) set no upper age limit and 18 (49%) stop at 75 or younger; 10 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 70 Years · female · no healthy volunteers.

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02

Study summary

The investigators aim to determine the effect of the correction of vitamin D in vitamin D deficient patients (\<15ng/ml) in oxidative stress and insulin resistance in patients with impaired glucose tolerance. Vitamin D deficiency has been associated with chronic low-grade inflammation, diabetes mellitus type 2, cardiovascular risk and increased prevalence of coronary heart disease, cerebrovascular disease and myocardial infarction.

03

Conditions studied

  • Vitamin D Deficiency
  • Glucose Intolerance
  • Oxidative Stress
  • Insulin Resistance
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women, 18 to 70 years, glucose intolerance (post-2 hour 75-grams glucose load > or equal 140 mg/dl), 25-hydroxy vitamin D concentration \< or equal 15 ng/ml

Exclusion criteria

Exclusion Criteria:

  • Diabetes, systemic inflammatory disorders, treatment with statins, metformin or fibrates, renal insufficiency, intestinal malabsorption
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Active

    Vitamin D 5000 units capsules, 20 capsules per week during four weeks (total 400,000 units)

    Drug: Vitamin D

  • Placebo comparator
    Placebo

    Identical placebo capsules, 20 capsules per week during four weeks

    Other: Placebo

Interventions

  • Vitamin D supplementation

    Also known as: Vitamin D3

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Change in anti-oxidant capacity measured in serum

    Change in serum anti-oxidant capacity after one month

    Time frame: One month

Secondary outcomes

  1. Change in homeostasis model assessment (HOMA) index measured in serum

    Change in homeostasis model assessment (HOMA) index after one month

    Time frame: One month

07

Study locations

1 site
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
    Mexico City, 14080, Mexico
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Jul 2022, 58 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2017
First posted
Nov 29, 2017
StartActual
Sep 1, 2017
Primary completionActual
Jul 18, 2022
CompletionActual
Jul 18, 2022
Last update
Mar 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03356873
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Sep 1, 2017
Primary completion
Jul 18, 2022
Completion
Jul 18, 2022
Last update
Mar 15, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin D

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