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NCT05694689
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
NA trial testing Placebo in Vitamin D Deficiency in 50 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | The University of Texas Health Science Center, Houston |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 50 |
| Start date | 15 February 2023 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 June 2029 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Placebo
- 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
- Usual Care
Conditions studied
- Vitamin D Deficiency — all drugs for Vitamin D Deficiency →
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
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05694689
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth
Trials testing the same drug.
- NCT05459298 — ViDES Trial (Vitamin D Extra Supplementation) · NA · active not recruiting
Other recruiting trials for Vitamin D Deficiency
Currently open trials in the same condition.
- NCT07317830 — Effects of Different Vitamin D3 Formulations in Vitamin D-Deficient Adults · NA · recruiting
- NCT07366970 — Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D? · NA · recruiting
- NCT07481240 — A Household-Based Dietary Intervention Study of Vitamin D Fortified Bread in Irish Families · NA · recruiting
- NCT07006714 — Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA) · Phase 4 · active not recruiting
- NCT07200011 — Effect of Vitamin D on the Clinical and Radiographic of Unsplinted Mandibular Implant Overdentures · active not recruiting
Other The University of Texas Health Science Center, Houston trials
Trials by the same sponsor.
- NCT04200729 — Povidone-iodine Irrigation for Prevention of Intra-abdominal Abscess in Pediatric Perforated Appendicitis: a Multi-cente · Phase 4 · not yet recruiting
- NCT07225062 — Improving HIV Prevention and Substance Use Post-Sexual Assault Services · NA · not yet recruiting
- NCT07396974 — Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT) · NA · not yet recruiting
- NCT07170163 — Navigating the Transition to Adulthood: A Dual Language Mobile App for Latino Youth With ASD and Their Families · NA · not yet recruiting
- NCT06915441 — Lipid Infusions to Optimize Nutrition Trial · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05694689 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Texas Health Science Center, Houston
- Last refreshed: 29 September 2025
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/NCT05694689.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing