Vitamin A DeficiencyPhase 3NCT03876704
Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants
A Phase 3 study testing High dose of fat-Soluble Vitamin and Conventional dose of fat-Soluble Vitamin in people with Vitamin A Deficiency and Vitamin D Deficiency, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency
- What is being tested?
- High dose of fat-Soluble Vitamin and Conventional dose of fat-Soluble Vitamin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2019to 31 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- liver enzymes elevated by more than 2 times, cholestasis
- death or discharge against medical advice
- refuse to take part in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xian JiaotongUniversity
Xi'an, Shaanxi, 710061
Xihui Zhou
About this study
Official title: Effects of Fat-soluble Vitamins Supplementation in Early Life on Common Complications and Neural Development in Very Low Birth Weight Infants
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
- Being tested
- High dose of fat-Soluble Vitamin, Conventional dose of fat-Soluble Vitamin
- Medical subject headings
- Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency, Bronchopulmonary Dysplasia, Anemia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose of fat-Soluble VitaminDrug
Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion
Conventional dose of fat-Soluble VitaminDrug
Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Conventional dose of fat-Soluble Vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin levels
Change from baseline level of vitamin A, vitamin D, and vitamin E at 4~6 weeks
Measured: within 72 hours after birth, 4~6 weeks old
Secondary outcomes (3)
Complications
The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc.
Measured: 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.
Measured: 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
Measured: within 72 hours after birth, 4~6 weeks old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start29 Jan 2019
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xi'an Gaoxin Hospital
- Responsible party
- Sponsor
- Investigators
- Shuang Liu, Study director, First Affiliated Hospital of Xian JiaotongUniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876704
- Sponsor's protocol ID
- 2018MSZC-04
- Status last verified
- Feb 2019
- First submitted
- 3 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21233795Mactier 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.
PubMed 21242240Jilani 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.
PubMed 30559825Cho 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.
PubMed 28472980Fares 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.
PubMed 24289974
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fat-soluble Vitamins Supplementation in Early Life on Common Complications and Neural Development in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT03876704
- Acronym / sponsor ID
- 2018MSZC-04
- Conditions
- Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency, Very Low Birth Weight Infants, Bronchopulmonary Dysplasia, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xi'an Gaoxin Hospital
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose of fat-soluble vitamins | Experimental | Drug: High dose of fat-Soluble VitaminFat-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. |
| Conventional dose of fat-soluble vitamins | Active comparator | Drug: Conventional dose of fat-Soluble VitaminFat-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. |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dose of fat-Soluble VitaminSupplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion | Drug | High dose of fat-soluble vitamins |
| Conventional dose of fat-Soluble VitaminSupplementation of the current dose of fat-soluble vitamins by intravenous perfusion | Drug | Conventional dose of fat-soluble vitamins |
Primary outcome
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
3 secondary outcomes
Complications
Time frame: corrected age of 36 weeks
Neural development
Time frame: corrected age of 40 weeks
Gene polymorphism in vitamin deficiency preterm infants
Time frame: within 72 hours after birth, 4~6 weeks old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Background: PubMed 21233795Kositamongkol 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.
- Background: PubMed 21242240Mactier 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.
- Background: PubMed 30559825Jilani 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.
- Background: PubMed 28472980Cho 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.
- Results publication: PubMed 24289974Fares 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuang Liu study director
First Affiliated Hospital of Xian JiaotongUniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing High dose of fat-Soluble Vitamin and Conventional dose of fat-Soluble Vitamin in people with Vitamin A Deficiency and Vitamin D Deficiency, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuang Liu (008615201524806, liushuangpku@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin levels (time frame: within 72 hours after birth, 4~6 weeks old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03876704, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.