Vitamin D Supplementation for Extremely Preterm Infants

Status Completed

Clinical Trial Summary

The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.

Clinical Trial Description

After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.

Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.

Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D [25(OH)D]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.

Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations >60ng/mL (>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.

All infants will be followed to discharge for primary, secondary outcomes as well as adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01600430
Study type	Interventional
Source	University of Alabama at Birmingham
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	June 2012
Completion date	December 2016

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04244474` - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children	Phase 1/Phase 2
Recruiting	`NCT05459298` - ViDES Trial (Vitamin D Extra Supplementation)	N/A
Completed	`NCT04476511` - The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules	Phase 3
Suspended	`NCT03652987` - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT03920150` - Vitamin D 24'000 IU for Oral Intermittent Supplementation	Phase 3
Completed	`NCT03264625` - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis	Phase 2
Completed	`NCT04183257` - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics	Phase 4
Recruiting	`NCT05084248` - Vitamin D Deficiency in Adults Following a Major Burn Injury	Phase 4
Completed	`NCT05506696` - Vitamin D Supplementation Study	N/A
Completed	`NCT00092066` - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227)	Phase 3
Completed	`NCT03234218` - Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Completed	`NCT02714361` - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women	N/A
Completed	`NCT03203382` - Corneal Nerve Structure in Sjogren's
Completed	`NCT02906319` - Vitamin D and HbA1c Levels in Diabetic Patients With CKD	N/A
Completed	`NCT02118129` - Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'.	N/A
Completed	`NCT02187146` - The Effects of Serum Vitamin D and IVF Outcome	N/A
Completed	`NCT02275650` - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter	N/A
Not yet recruiting	`NCT01419821` - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5	N/A
Completed	`NCT01741181` - Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2	Phase 4
Completed	`NCT01688102` - The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile	N/A