Other Preterm InfantsNCT02404623
The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity
A study testing Vitamin D in people with Other Preterm Infants and Vitamin D Deficiency, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants. This is a prospective randomized (1:1) double-blinded trial. Read more about this study
- Who is it for?
- Ages 33 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Other Preterm Infants, Vitamin D Deficiency, Bronchiolitis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2015to 12 Feb 2018
- 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 33 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infant born at 32+6 to 36+6 weeks of gestational age
- Born at Soroka University Medical Center
- Signed informed consent
- Participants in the trial will be insured by "Clalit" HMO
Who cannot join
- Chromosomal abnormality
- Neurological or muscular congenital anomalies
- Congenital cardiac defect
- Congenital respiratory anomalies
- Congenital GIT/ liver/ renal anomalies that effect the absorption and/or metabolism of Vitamin D and/or other substances.
- Admission after birth to NICU persists more than 5 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity During the First Year of Life
This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants.
This is a prospective randomized (1:1) double-blinded trial.
The study population will be randomized into two groups (1:1):
- Intervention Group - 800 IU of Vitamin D once daily
- Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year after randomization for serum Vitamin D levels and respiratory morbidity.
Read the detailed description
The rational of this trial is that a daily supplementation of a double dose of Vitamin D (800 IU instead of 400 IU) to late premature infants during the first year of life will result in elevated Vitamin D serum levels and in an improvement in respiratory morbidity.
This randomized trial of vitamin D supplementation is planned to determine the optimal dose of daily vitamin D supplementation required to achieve sufficient vitamin D levels in preterm infants and to assess whether doubling the daily intake of vitamin D may serve as primary prevention of respiratory infections and asthma in premature infants.
- Conditions
- Other Preterm Infants, Vitamin D Deficiency, Bronchiolitis, Asthma, Pneumonia
- Being tested
- Vitamin D
- Keywords
- Vitamin D, Respiratory Morbidity, prematurity
- Medical subject headings
- Vitamin D Deficiency, Bronchiolitis, Asthma, Pneumonia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
also known as Cholecalciferol, is one of the two most important compounds within the group of Vitamin D. It can be ingested from the diet and from supplements. In this study it is pharmacologically acquired and referred to as Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 800 IU of Vitamin D once daily Receives: Dietary Supplement: Vitamin D |
| Control Group | Other | 400 IU of Vitamin D once daily, the standard of care Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily)
Measured: 12 months of age
Secondary outcomes (3)
respiratory morbidity prevalence
Reports given by the parents via questionnaire at 3, 6, 9 and 12 months.
Measured: first year
respiratory morbidity prevalence
Information collected from medical records containing the data of diagnosis or admission to pediatrics departments due to: bronchiolitis, wheezing, upper or lower respiratory tract infections, asthma and pneumonia
Measured: first year
respiratory morbidity prevalence
Information collected from medical records containing the data of medication consumption such as bronchodilators, inhaled corticosteroid, systemic corticosteroids (along with respiratory disease) and antibiotics (along with respiratory infection).
Measured: first year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startApr 2015
- Primary completion12 Feb 2018
- Study completion12 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Other Preterm InfantsStudies 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, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inbal Golan- Tripto MD, Soroka University Medical Center
- Investigators
- Inbal Golan Tripto, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404623
- Sponsor's protocol ID
- SOR -0292-14-CTIL
- Status last verified
- Feb 2018
- First submitted
- 18 Mar 2015
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
PubMed 33305842
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity During the First Year of Life
- ClinicalTrials.gov ID
- NCT02404623
- Acronym / sponsor ID
- SOR -0292-14-CTIL
- Conditions
- Other Preterm Infants, Vitamin D Deficiency, Bronchiolitis, Asthma, Pneumonia
- Keywords
- Vitamin D, Respiratory Morbidity, prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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.
This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants.
This is a prospective randomized (1:1) double-blinded trial.
The study population will be randomized into two groups (1:1):
- Intervention Group - 800 IU of Vitamin D once daily
- Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year after randomization for serum Vitamin D levels and respiratory morbidity.
Detailed description
The rational of this trial is that a daily supplementation of a double dose of Vitamin D (800 IU instead of 400 IU) to late premature infants during the first year of life will result in elevated Vitamin D serum levels and in an improvement in respiratory morbidity.
This randomized trial of vitamin D supplementation is planned to determine the optimal dose of daily vitamin D supplementation required to achieve sufficient vitamin D levels in preterm infants and to assess whether doubling the daily intake of vitamin D may serve as primary prevention of respiratory infections and asthma in premature infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Vitamin D800 IU of Vitamin D once daily |
| Control Group | Other | Dietary Supplement: Vitamin D400 IU of Vitamin D once daily, the standard of care |
Who may qualify
- Ages
- 33 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Preterm infant born at 32+6 to 36+6 weeks of gestational age
- Born at Soroka University Medical Center
- Signed informed consent
- Participants in the trial will be insured by "Clalit" HMO
Key exclusion criteria (6 listed)
- Chromosomal abnormality
- Neurological or muscular congenital anomalies
- Congenital cardiac defect
- Congenital respiratory anomalies
- Congenital GIT/ liver/ renal anomalies that effect the absorption and/or metabolism of Vitamin D and/or other substances.
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 Dalso known as Cholecalciferol, is one of the two most important compounds within the group of Vitamin D. It can be ingested from the diet and from supplements. In this study it is pharmacologically acquired and referred to as Vitamin D | Dietary supplement | Control Group, Intervention Group |
Primary outcome
Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily)
Time frame: 12 months of age
3 secondary outcomes
respiratory morbidity prevalence
Time frame: first year
respiratory morbidity prevalence
Time frame: first year
respiratory morbidity prevalence
Time frame: first 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 14 Feb 2018.
- Derived from this study: PubMed 33305842Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
- Individual participant dataSharing planned: Yes
Related trials for Other Preterm Infants
Recruiting
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
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.
Inbal Golan Tripto, MD principal investigator
Soroka University Medical Center
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 D in people with Other Preterm Infants and Vitamin D Deficiency, run by Soroka University Medical Center at 1 site in Israel.
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 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 14 Feb 2018. 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 Israel. 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.
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?
Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily) (time frame: 12 months of age). 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 NCT02404623, which also lists 1 linked publication.
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 14 Feb 2018.