A Phase 3 interventional study of High dose of fat-Soluble Vitamin and Conventional dose of fat-Soluble Vitamin in Vitamin A Deficiency, Vitamin D Deficiency and Vitamin E Deficiency, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged Up to 24 Hours. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 3, Interventional, and Treatment
Vitamins A, D, and E play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance. Deficiencies in these vitamins will result in a high prevalence of cardiovascular disease, infection, bone diseases, etc. Preterm infants, especially very low birth weight infants, are at risk of vitamin deficiency. Intravenous perfusion is the most common and widely used method to supply vitamins for the specific population in early life. However, the current dose of vitamin supplied by intravenous perfusion whether can meet the need of growth and development is not sure and the appropriate dose for preterm infants is still uncertain. The purpose of this study is to investigate whether current dose of fat-soluble vitamin supplementation is enough for very low birth weight infants, the safety of high dose of fat-soluble vitamin supplementation, and compare the differences of prevalence of common complications, such as bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, and neural development between these two groups.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's planned enrollment of 120 is below the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fat-soluble vitamins is administered 0.5 piece/kg (equals to 1150 U/kg vitamin A，200 U/kg vitamin D, 3.2 U/kg vitamin E) intravenously every day until the baby achieve full enteral feeding (120 ml/kg), starting with the first dose within 24 hours after birth.
Drug: High dose of fat-Soluble Vitamin
Fat-soluble vitamins is administered 0.1 piece/kg (equals to 230 U/kg vitamin A，40 U/kg vitamin D, 0.64 U/kg vitamin E) intravenously every day until the baby achieve full enteral feeding (120 ml/kg), starting with the first dose within 24 hours after birth.
Drug: Conventional dose of fat-Soluble Vitamin
Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion
Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion
Vitamin levels
Change from baseline level of vitamin A, vitamin D, and vitamin E at 4\~6 weeks
Time frame: within 72 hours after birth, 4~6 weeks old
Complications
The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.
Time frame: corrected age of 36 weeks
Neural development
White matter disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method.
Time frame: corrected age of 40 weeks
Gene polymorphism in vitamin deficiency preterm infants
Association of rs4588 polymorphism in vitamin D receptor gene and rs10766197 polymorphism in the cytochrome P450 family 2 subfamily R member 1 gene with baseline level of vitamin D and change in vitamin D level after 4\~6 weeks' supplementation
Time frame: within 72 hours after birth, 4~6 weeks old
Plan to share: Undecided
Started Jan 2019 (actual). Primary completion is estimated for Sep 2019, 8 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University →