Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants

NCT03876704 | Unknown Phase 3 DMC

• 1 other identifier: 2018MSZC-04
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitamin A Deficiency; Vitamin D Deficiency; Vitamin E Deficiency; Very Low Birth Weight Infants; Bronchopulmonary Dysplasia; Anemia; Sepsis

Outcome Measures

Primary Outcomes (1)

• Vitamin levels

  Change from baseline level of vitamin A, vitamin D, and vitamin E at 4\~6 weeks

  within 72 hours after birth, 4~6 weeks old

Secondary Outcomes (3)

• Complications

  corrected age of 36 weeks

• Neural development

  corrected age of 40 weeks

• Gene polymorphism in vitamin deficiency preterm infants

  within 72 hours after birth, 4~6 weeks old

Study Arms (2)

High dose of fat-soluble vitamins

EXPERIMENTAL

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

Conventional dose of fat-soluble vitamins

ACTIVE COMPARATOR

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

Interventions

High dose of fat-Soluble Vitamin DRUG

Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion

High dose of fat-soluble vitamins

Conventional dose of fat-Soluble Vitamin DRUG

Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion

Conventional dose of fat-soluble vitamins

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• admitted to the neonatal intensive care unit (NICU) within 24 hours after birth
• gestational age younger than 34 weeks
• birth weight less than 1500 gram
• informed consent was obtained from the infants' parents or guardians

You may not qualify if:

• congenital malformation
• chromosomal disease, genetic metabolic diseases
• the infants or his/mother has abnormal thyroid function or parathyroid gland function
• neonatal necrotizing enterocolitis, diarrhea
• intracranial hemorrhage of 3 degrees or above
• pulmonary hemorrhage
• liver enzymes elevated by more than 2 times, cholestasis
• death or discharge against medical advice
• refuse to take part in the study

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Xi'an Gaoxin Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (5)

• Kositamongkol S, Suthutvoravut U, Chongviriyaphan N, Feungpean B, Nuntnarumit P. Vitamin A and E status in very low birth weight infants. J Perinatol. 2011 Jul;31(7):471-6. doi: 10.1038/jp.2010.155. Epub 2011 Jan 13.

  PMID: 21233795 BACKGROUND

• Mactier H, Mokaya MM, Farrell L, Edwards CA. Vitamin A provision for preterm infants: are we meeting current guidelines? Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F286-9. doi: 10.1136/adc.2010.190017. Epub 2011 Jan 17.

  PMID: 21242240 BACKGROUND

• Jilani T, Iqbal MP. Vitamin E deficiency in South Asian population and the therapeutic use of alpha-tocopherol (Vitamin E) for correction of anemia. Pak J Med Sci. 2018 Nov-Dec;34(6):1571-1575. doi: 10.12669/pjms.346.15880.

  PMID: 30559825 BACKGROUND

• Cho SY, Park HK, Lee HJ. Efficacy and safety of early supplementation with 800 IU of vitamin D in very preterm infants followed by underlying levels of vitamin D at birth. Ital J Pediatr. 2017 May 4;43(1):45. doi: 10.1186/s13052-017-0361-0.

  PMID: 28472980 BACKGROUND

• Fares S, Sethom MM, Khouaja-Mokrani C, Jabnoun S, Feki M, Kaabachi N. VitaminA, E, and D deficiencies in tunisian very low birth weight neonates: prevalence and risk factors. Pediatr Neonatol. 2014 Jun;55(3):196-201. doi: 10.1016/j.pedneo.2013.09.006. Epub 2013 Nov 26.

  PMID: 24289974 RESULT

MeSH Terms

Conditions

Vitamin A Deficiency; Vitamin D Deficiency; Vitamin E Deficiency; Bronchopulmonary Dysplasia; Anemia; Sepsis

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hematologic Diseases; Hemic and Lymphatic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shuang Liu

  First Affiliated Hospital of Xian JiaotongUniversity

  STUDY DIRECTOR

Central Study Contacts

Shuang Liu

CONTACT

008615201524806; liushuangpku@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 15, 2019
• Study Start: January 29, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2020
• Last Updated: March 15, 2019

Record last verified: 2019-02

Locations

CN (1)