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NCT01488734 · ClinicalTrials.gov registry record · NA

Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom

A NA study, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
NA
Development phase
47
Enrollment target

NCT01488734: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT01488734 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01488734, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
NA
Development phase
47 participants
Enrollment target

Study Summary

The purpose of this study is to compare the safety and efficacy of two different amounts of vitamin D2 (600 or 4000 International Units/day) provided by mushrooms added to one of the daily meals versus same doses of vitamin D3 provided as oral supplements sold in any drugstore in reaching adequate or optimal blood levels of 25(OH)D in people with Vitamin D deficiency and pre-diabetes (high blood sugar without full blown diabetes) or the metabolic syndrome. Metabolic syndrome is the name of a group of risk factors that raise the risk for heart disease and other health problems, such as diabetes and stroke as described by the US department of Health and Human Services. This study will also attempt to demonstrate and compare the effect of the intervention with above two doses of vitamin D on blood levels of tests that show inflammation.

Primary Outcome

To compare the efficacy of two different doses of vitamin D2 (600 or 4000 IU/day) provided by Vitamin D2 fortified mushrooms added to one of the daily meals versus same doses of vitamin D3 provided as oral supplements in reaching adequate or optimal circulating levels of 25(OH) D in a racially diverse group of subjects with Vitamin D deficiency and pre-diabetes or the metabolic syndrome.

Interventions

  • DRUG Placebo
  • DIETARY_SUPPLEMENT Mushroom with 600 IU vitamin D2
  • DIETARY_SUPPLEMENT Mushroom with 4000 IU Vitamin D2
  • DIETARY_SUPPLEMENT 600 IU Vitamin D3 and untreated mushroom
  • DIETARY_SUPPLEMENT 4000 IU Vitamin D3 and untreated mushroom

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2011-11
Est. Completion 2013-09
Phase NA

What the finished NCT01488734 record still lists

NCT01488734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT01488734 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01488734 about?

NCT01488734 is a clinical study titled "Bioavailability and Biological Effects of Vitamin D2 Contained in Mushroom". The purpose of this study is to compare the safety and efficacy of two different amounts of vitamin D2 (600 or 4000 International Units/day) provided by mushrooms added to one of the daily meals versus same doses of vitamin D3 provided as oral supplements sold in any drugstore in reaching adequate o...

What is the current status of trial NCT01488734?

This trial is currently completed. It is a NA study. The enrollment target is 47 participants. The study started on 2011-11. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01488734?

The interventions under investigation include: Placebo (DRUG), Mushroom with 600 IU vitamin D2 (DIETARY_SUPPLEMENT), Mushroom with 4000 IU Vitamin D2 (DIETARY_SUPPLEMENT), 600 IU Vitamin D3 and untreated mushroom (DIETARY_SUPPLEMENT), 4000 IU Vitamin D3 and untreated mushroom (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01488734?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01488734's enrollment target sits among peer trials

47 1400th of 2000 higher than 599 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01488734, the US trial registry maintained by the National Library of Medicine. NCT01488734 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.