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NCT05459298

ViDES Trial (Vitamin D Extra Supplementation)

Active, enrolled NA Last updated 29 September 2025
What this trial tests

NA trial testing Placebo in Vitamin D Deficiency in 180 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
6 September 2022
Primary endpoint
12 August 2025
1 December 2027

Quick facts

Lead sponsorThe University of Texas Health Science Center, Houston
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeother
Enrollment180
Start date6 September 2022
Primary completion12 August 2025
Estimated completion1 December 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Health Science Center, Houston

Who can join

Adults 24 Hours to 96 Hours, any sex, with Vitamin D Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Randomized controlled trial of enteral vitamin D supplementation (ViDES) in infants <28 weeks gestational age or <1000 g birth weight: study protocol.
    Romero-Lopez M, Tyson JE, Naik M, Pedroza C, et al · · 2024 · cited 3× · PMID 38943179 · DOI 10.1186/s13063-024-08274-8
  2. Necrotizing Enterocolitis: What's New and What's Next?
    Sha C, Sander WR, Bass K, Hsieh H, et al · · 2025 · cited 1× · PMID 41096926 · DOI 10.3390/ijms26199660
  3. Randomized Controlled Trial of Enteral Vitamin D Supplementation (ViDES) in Infants &lt;28 Weeks Gestational Age or &lt;1000 Grams Birth Weight: Study Protocol
    Romero-Lopez M, Tyson JE, Naik M, Pedroza C, et al · · 2024 · DOI 10.21203/rs.3.rs-4049246/v1

Verify or expand the search:

Other trials of 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth

Trials testing the same drug.

Other recruiting trials for Vitamin D Deficiency

Currently open trials in the same condition.

Other The University of Texas Health Science Center, Houston trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05459298.

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