Vitamin D Deficiency Clinical Trial
Official title:
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. A Randomized Controlled Study.
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.
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. ;
| 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 | |
| Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
| Completed |
NCT04476511 -
The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules
|
Phase 3 | |
| 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 |
NCT03203382 -
Corneal Nerve Structure in Sjogren's
|
||
| Completed |
NCT02906319 -
Vitamin D and HbA1c Levels in Diabetic Patients With CKD
|
N/A | |
| Completed |
NCT02714361 -
A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
|
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 |
NCT01688102 -
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
|
N/A | |
| Completed |
NCT01651000 -
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
|
Phase 3 |