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NCT05694689 · ClinicalTrials.gov registry record · NA

Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight

A NA study of Vitamin D Deficiency, sponsored by The University of Texas Health Science Center, Houston.

Recruiting
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT05694689 is a NA study of Vitamin D Deficiency that is actively recruiting participants, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 50 participants, below the 275-participant average among 48 other Vitamin D Deficiency trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05694689, a NA study of Vitamin D Deficiency, is actively recruiting participants, sponsored by The University of Texas Health Science Center, Houston.

RECRUITING
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).

Conditions Studied

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • OTHER Usual Care
  • DIETARY_SUPPLEMENT 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth

Study Locations (1)

Texas

  • The University of Texas Medical Branch - Galveston

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2023-02-15
Est. Completion 2029-06-01
Phase NA

What the Registry Record Tells You About NCT05694689

The ClinicalTrials.gov registry entry for NCT05694689 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 275-participant average among 48 other Vitamin D Deficiency trials with a reported enrollment target (82% lower). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Vitamin D Deficiency appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT05694689 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT05694689 about?

NCT05694689 is a clinical study titled "Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight". The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, i...

What is the current status of trial NCT05694689?

This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2023-02-15. Estimated completion is 2029-06-01.

What conditions does trial NCT05694689 study?

This clinical trial studies the following conditions: Vitamin D Deficiency.

What interventions are being tested in trial NCT05694689?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Usual Care (OTHER), 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05694689?

This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05694689 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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