Clinical Trials Logo
  1. Home
  2. Vitamin D Deficiency
  3. NCT06199102

The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. — HIDVID  

Vitamin D Deficiency Clinical Trial

Official title:
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. A Randomized Controlled Study.

Clinical Trial Summary

The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.

Clinical Trial Description

Vitamin D deficiency can escalate prematurity bone disease in preterm infants and negatively influence their immature immunology system. Infants born at 24+0/7 weeks to 32+6/7 weeks of gestation will be considered for inclusion. Cord or vein blood samples will be obtained within 48 h after birth for 25-hydroxyvitamin D level measurements. Parathyroid hormone and interleukin-6 levels will be measured. Infants will be randomized to the monitored group (i.e., initial dose of 1000 IU/day and possible modification) or the controlled group (i.e., 250 IU/day or 500 IU/day dose, depending on weight). Supplementation will be monitored up to postconceptional age 35 weeks. The primary endpoint is the percentage of infants with deficient or suboptimal 25-hydroxyvitamin D levels at 28±2 days of age. 25-Hydroxyvitamin D levels will be measured at postconceptional age 35±2 weeks. Secondary objectives include the incidence of sepsis, osteopenia, hyperparathyroidism, and elevated interleukin-6 concentration. The aim of this study will be to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants and to determine whether a high initial dose of monitored vitamin D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06199102
Study type Interventional
Source Princess Anna Mazowiecka Hospital, Warsaw, Poland
Contact Dominika M Paw, MD
Phone 22 596 61 36
Email dominika.paw@wum.edu.pl
Status Not yet recruiting
Phase N/A
Start date September 1, 2024
Completion date December 31, 2027
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
Not yet recruiting NCT01419821 - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5 N/A
Completed NCT02275650 - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter N/A
Completed NCT02187146 - The Effects of Serum Vitamin D and IVF Outcome N/A
Completed NCT01688102 - The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile N/A
Completed NCT01741181 - Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2 Phase 4