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NCT04118010 · ClinicalTrials.gov registry record · Phase 4

Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

A Phase 4 study, sponsored by Emory University.

Completed
Registry status
Phase 4
Development phase
40
Enrollment target

NCT04118010: Completed Phase 4 study, sponsored by Emory University.

NCT04118010 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04118010, a Phase 4 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 4
Development phase
40 participants
Enrollment target

Study Summary

The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis with the additive or synergistic effects of the combination of vitamin D + inulin.

Primary Outcome

The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -∑(i=1)\^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community. Sputum microbiota analysis was measured using this e

Interventions

  • DRUG Inulin
  • DRUG Vitamin D3
  • DRUG Placebo vitamin D3
  • DRUG Placebo Inulin

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2020-03-13
Est. Completion 2022-12-31
Phase Phase 4
Emory University

1,208 total trials

What the finished NCT04118010 record still lists

NCT04118010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 4 interventions - of which Inulin is the first listed.

NCT04118010 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04118010 about?

NCT04118010 is a clinical study titled "Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis". The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis with the additive or synergistic effects of the combination of vitamin D + inulin.

What is the current status of trial NCT04118010?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2020-03-13. Estimated completion is 2022-12-31.

What interventions are being tested in trial NCT04118010?

The interventions under investigation include: Inulin (DRUG), Vitamin D3 (DRUG), Placebo vitamin D3 (DRUG), Placebo Inulin (DRUG).

Who is sponsoring clinical trial NCT04118010?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04118010's enrollment target sits among peer trials

40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT04118010, the US trial registry maintained by the National Library of Medicine. NCT04118010 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.