Efficacy and SafetyNCT03779776
The Efficacy and Safety of Early Vitamin AD Supplementation in Very Preterm Infants
A study testing Vitamin AD in people with Efficacy and Safety, run by Zhengzhou Children's Hospital, China at 1 site in China.
Trial summary
Bronchopulmonary dysplasia (BPD) is the most prevalent longterm morbidity among surviving extremely preterm infants and has a multifactorial etiology. BPD is associated with later risk of reactive airways disease, such as asthma, post neonatal mortality and adverse neurodevelopmental outcomes.Retinopathy of… Read more about this study
- Who is it for?
- Ages 1 hour to 96 hours
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- Vitamin AD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 676 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 28 Jun 2020
- Phase
- Interventional
- 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 1 hour to 96 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age<32 weeks,
- <96 hours of age
Who cannot join
- genetic metabolic diseases;
- congenital major abnormalities;
- congenital non-bacterial infection with overt signs at birth;
- terminal stage of illness (pH < 7.0 or hypoxia with bradycardia>2 h);
- ≥ grade III intracranial hemorrhage;
- lacking parental consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Department of Neonatology, Zhengzhou Children's Hospital
Bronchopulmonary dysplasia (BPD) is the most prevalent longterm morbidity among surviving extremely preterm infants and has a multifactorial etiology. BPD is associated with later risk of reactive airways disease, such as asthma, post neonatal mortality and adverse neurodevelopmental outcomes.Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and a major cause of vision impairment or blindness in preterm infants, even with aggressed current standard care.Accumulating epidemiologic evidence suggests that vitamin D (VD) deficiency or insufficiency is associated with respiratory disease and metabolic bone disease in premature children.Vitamin A (VA) plays an integral part in lung growth and differentiation. VA is an essential micronutrient for normal visual function.
Our prospective double-blinded randomized controlled trial will include infants born at <32 weeks' gestation and admitted to six tertiary NICUs in China. Infants in the intervention (vitamin AD drops) group will receive the daily dose VA at 1500 IU/day with VD 500 IU/day, added to their enteral feeds in drop form as soon as minimal feeding was introduced, and continued to 28 days or discharge. Infants in the control group will receive an equivalent volume of a placebo solution. Following informed consent, enrolled infants will be randomly allocated to the control or VAD group. The primary outcome is bronchopulmonary dysplasia (BPD) , ROP, or metabolic bone disease and the secondary outcomes are mortality; NEC ≥ stage 2; ; late-onset sepsis; weight gain, change in weight, increase in length, increase in head circumference; time to full enteral feeds; and number and type of critical incident reports.
- Conditions
- Efficacy and Safety
- Being tested
- Vitamin AD, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADOther
In Vitamin AD group, the very preterm infants will receive the daily vitamin AD with vitamin A at 1500 IU/day and vitamin D at 500 IU/day in drop form added to their enteral feeds when minimal feeding is introduced, and continue to 28 days or discharge. In this group ,the patient also will receive standard intravenous multivitamin preparation (1 ml/kg/d,containing VA 230 IU/kg/d, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.
ControlOther
In this group ,the patient will only receive standard intravenous multivitamin preparation (1 ml/kg/d,containing VA 230 IU/kg/d, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin AD | Experimental | In Vitamin AD group, the very preterm infants will receive the daily vitamin AD with vitamin A at1500 IU/day and vitamin D at 500 IU/day in drop form added to their enteral feeds when minimal feeding is introduced, and continue to 28 days or discharge. In this group ,the patient also will receive standard intravenous multivitamin preparation (1 ml/kg/d, containing VA 230 IU/kg/d, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg. Receives: Other: Vitamin AD |
| Control | Placebo comparator | In this group ,the patient will only receive standard intravenous multivitamin preparation (1 ml/kg/d,containing VA 230 IU/kg/d,VD 80 IU/kg/d ) within daily on parenteral nutrition until fed 120ml/kg. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
rates of bronchopulmonary dysplasia
The rates of bronchopulmonary dysplasia with early vitamin AD supplementation
Measured: 1 year
rates of retinopathy of prematurity
The rates of retinopathy of prematurity with early vitamin AD supplementation
Measured: 1 year
Metaboloc bone disease
The rates of Metaboloc bone disease of prematurity with early vitamin AD supplementation
Measured: 1 year
Secondary outcomes (1)
rates of Necrotizing enterocolitis
The rates of Necrotizing enterocolitis with early vitamin AD supplementation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jul 2018
- Primary completion28 Jun 2020
- Study completion28 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and SafetyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou Children's Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiqing Sun, Zhengzhou Children's Hospital, China
- Investigators
- Shuying Luo, MD, Study director, Zhengzhou Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779776
- Sponsor's protocol ID
- VAD-PRETERM
- Status last verified
- Oct 2020
- First submitted
- 12 Dec 2018
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Department of Neonatology, Zhengzhou Children's Hospital
- ClinicalTrials.gov ID
- NCT03779776
- Acronym / sponsor ID
- VAD-PRETERM
- Conditions
- Efficacy and Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- Zhengzhou Children's Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 28 Jun 2020 (actual)
- Study completion
- 28 Jun 2020 (actual)
- First posted
- 19 Dec 2018 (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.
Bronchopulmonary dysplasia (BPD) is the most prevalent longterm morbidity among surviving extremely preterm infants and has a multifactorial etiology. BPD is associated with later risk of reactive airways disease, such as asthma, post neonatal mortality and adverse neurodevelopmental outcomes.Retinopathy of prematurity (ROP) is a common retinal neovascular disorder and a major cause of vision impairment or blindness in preterm infants, even with aggressed current standard care.Accumulating epidemiologic evidence suggests that vitamin D (VD) deficiency or insufficiency is associated with respiratory disease and metabolic bone disease in premature children.Vitamin A (VA) plays an integral part in lung growth and differentiation. VA is an essential micronutrient for normal visual function.
Our prospective double-blinded randomized controlled trial will include infants born at <32 weeks' gestation and admitted to six tertiary NICUs in China. Infants in the intervention (vitamin AD drops) group will receive the daily dose VA at 1500 IU/day with VD 500 IU/day, added to their enteral feeds in drop form as soon as minimal feeding was introduced, and continued to 28 days or discharge. Infants in the control group will receive an equivalent volume of a placebo solution. Following informed consent, enrolled infants will be randomly allocated to the control or VAD group. The primary outcome is bronchopulmonary dysplasia (BPD) , ROP, or metabolic bone disease and the secondary outcomes are mortality; NEC ≥ stage 2; ; late-onset sepsis; weight gain, change in weight, increase in length, increase in head circumference; time to full enteral feeds; and number and type of critical incident reports.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin AD | Experimental | Other: Vitamin ADIn Vitamin AD group, the very preterm infants will receive the daily vitamin AD with vitamin A at1500 IU/day and vitamin D at 500 IU/day in drop form added to their enteral feeds when minimal feeding is introduced, and continue to 28 days or discharge. In this group ,the patient also will receive standard intravenous multivitamin preparation (1 ml/kg/d, containing VA 230 IU/kg/d, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg. |
| Control | Placebo comparator | Other: ControlIn this group ,the patient will only receive standard intravenous multivitamin preparation (1 ml/kg/d,containing VA 230 IU/kg/d,VD 80 IU/kg/d ) within daily on parenteral nutrition until fed 120ml/kg. |
Who may qualify
- Ages
- 1 hour to 96 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- gestational age<32 weeks,
- <96 hours of age
Key exclusion criteria (6 listed)
- genetic metabolic diseases;
- congenital major abnormalities;
- congenital non-bacterial infection with overt signs at birth;
- terminal stage of illness (pH < 7.0 or hypoxia with bradycardia>2 h);
- ≥ grade III intracranial hemorrhage;
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 |
|---|---|---|
| Vitamin ADIn Vitamin AD group, the very preterm infants will receive the daily vitamin AD with vitamin A at 1500 IU/day and vitamin D at 500 IU/day in drop form added to their enteral feeds when minimal feeding is introduced, and continue to 28 days or discharge. In this group ,the patient also will receive standard intravenous multivitamin preparation (1 ml/kg/d,containing VA 230 IU/kg/d, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg. | Other | Vitamin AD |
| ControlIn this group ,the patient will only receive standard intravenous multivitamin preparation (1 ml/kg/d,containing VA 230 IU/kg/d, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg. | Other | Control |
Primary outcome
rates of bronchopulmonary dysplasia
Time frame: 1 year
The rates of bronchopulmonary dysplasia with early vitamin AD supplementation
rates of retinopathy of prematurity
Time frame: 1 year
The rates of retinopathy of prematurity with early vitamin AD supplementation
Metaboloc bone disease
Time frame: 1 year
The rates of Metaboloc bone disease of prematurity with early vitamin AD supplementation
1 secondary outcome
rates of Necrotizing enterocolitis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Shuying Luo, MD study director
Zhengzhou Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin AD in people with Efficacy and Safety, run by Zhengzhou Children's Hospital, China 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 10 Sep 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rates of bronchopulmonary dysplasia (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2021.