Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants
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|ClinicalTrials.gov Identifier: NCT03876704|
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vitamin A Deficiency Vitamin D Deficiency Vitamin E Deficiency Very Low Birth Weight Infants Bronchopulmonary Dysplasia Anemia Sepsis||Drug: High dose of fat-Soluble Vitamin Drug: Conventional dose of fat-Soluble Vitamin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effects of Fat-soluble Vitamins Supplementation in Early Life on Common Complications and Neural Development in Very Low Birth Weight Infants|
|Actual Study Start Date :||January 29, 2019|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: High dose of fat-soluble vitamins
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
Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion
Active Comparator: Conventional dose of fat-soluble vitamins
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 the current dose of fat-soluble vitamins by intravenous perfusion
- Vitamin levels [ Time Frame: within 72 hours after birth, 4~6 weeks old ]Change from baseline level of vitamin A, vitamin D, and vitamin E at 4~6 weeks
- Complications [ Time Frame: corrected age of 36 weeks ]The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.
- Neural development [ Time Frame: corrected age of 40 weeks ]White matter disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method.
- Gene polymorphism in vitamin deficiency preterm infants [ Time Frame: within 72 hours after birth, 4~6 weeks old ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876704
|Contact: Shuang Liufirstname.lastname@example.org|
|First Affiliated Hospital of Xian JiaotongUniversity||Recruiting|
|Xi'an, Shaanxi, China, 710061|
|Contact: Xihui Zhou|
|Study Director:||Shuang Liu||First Affiliated Hospital of Xian JiaotongUniversity|