Vitamin D DeficiencyPhase 4NCT02941185
Multi-dose Vitamin D Supplementation in Preterm Infants
A Phase 4 study testing Devit-3 Oral Drop in people with Vitamin D Deficiency and Preterm Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants. Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Vitamin D Deficiency, Preterm Infants
- What is being tested?
- Devit-3 Oral Drop
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Dec 2016
- Phase
- Phase 4
- 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 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with gestational age 24 to 32 weeks who achieved at least 75% of total nutrition by enteral feedings in postnatal 2 weeks
Who cannot join
- perinatal asphyxia,
- major congenital or chromosomal anomalies,
- those with no expectation of survival in first 2 weeks
- those that total parenteral nutrition was not ceased by the first 2 weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Women's Health and Education Hospital
Ankara, 06230
About this study
Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants.
Read the detailed description
Vitamin D is a fat-soluble vitamin that is either taken by dietary sources or synthesized upon exposure to sun light. Although major function is on bone metabolism, in recent years other effects of Vitamin D attracted attention. Low neonatal vitamin D levels were reported to be associated with increased risk of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD) and sepsis.
Vitamin D level in the fetus and the newborn is mostly dependent on maternal vitamin D levels. Most of the vitamin D is transferred to the fetus during third trimester and as a result preterm newborns especially those with <32 weeks gestational age are born with lower vitamin D stores. But there is no consensus regarding the adequate dose of vitamin D supplementation for preterm infants. The American Academy of Pediatrics recommends supplementation of 200-400 IU/d vitamin D for preterm infants. And the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends 800-1000 IU/d vitamin D supplementation for preterm infants.
- Conditions
- Vitamin D Deficiency, Preterm Infants
- Being tested
- Devit-3 Oral Drop
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Devit-3 Oral DropDrug
| Study group | Role | What they receive |
|---|---|---|
| Devit-3 Oral Drop 400 IU | Other | supplemented with oral Vitamin D 400 IU/day (Devit-3 Oral Drop, 50000 IU/15 ml, Deva Company, Turkey) started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age Receives: Drug: Devit-3 Oral Drop |
| Devit-3 Oral Drop 800 IU | Active comparator | Devit-3 Oral Drop 800 IU once daily by oral route started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age Receives: Drug: Devit-3 Oral Drop |
| Devit-3 Oral Drop 1000 IU | Active comparator | Devit-3 Oral Drop1000 IU once daily by oral route started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age Receives: Drug: Devit-3 Oral Drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of 25(OH) D at 36 weeks postmenstrual age.
Measured: 36 weeks
Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Bozkurt, MD, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941185
- Sponsor's protocol ID
- ZTB2015
- Status last verified
- Feb 2017
- First submitted
- 18 Oct 2016
- Last updated
- 6 Feb 2017
- Results posted
- No
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 33305842Bozkurt O, Uras N, Sari FN, Atay FY, Sahin S, Alkan AD, Canpolat FE, Oguz SS. Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses. Early Hum Dev. 2017 Sep;112:54-59. doi: 10.1016/j.earlhumdev.2017.07.016. Epub 2017 Aug 2.
PubMed 28779655
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-dose Vitamin D Supplementation in Preterm Infants
- ClinicalTrials.gov ID
- NCT02941185
- Acronym / sponsor ID
- ZTB2015
- Conditions
- Vitamin D Deficiency, Preterm Infants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 21 Oct 2016 (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.
Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants.
Detailed description
Vitamin D is a fat-soluble vitamin that is either taken by dietary sources or synthesized upon exposure to sun light. Although major function is on bone metabolism, in recent years other effects of Vitamin D attracted attention. Low neonatal vitamin D levels were reported to be associated with increased risk of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD) and sepsis.
Vitamin D level in the fetus and the newborn is mostly dependent on maternal vitamin D levels. Most of the vitamin D is transferred to the fetus during third trimester and as a result preterm newborns especially those with <32 weeks gestational age are born with lower vitamin D stores. But there is no consensus regarding the adequate dose of vitamin D supplementation for preterm infants. The American Academy of Pediatrics recommends supplementation of 200-400 IU/d vitamin D for preterm infants. And the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends 800-1000 IU/d vitamin D supplementation for preterm infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Devit-3 Oral Drop 400 IU | Other | Drug: Devit-3 Oral Dropsupplemented with oral Vitamin D 400 IU/day (Devit-3 Oral Drop, 50000 IU/15 ml, Deva Company, Turkey) started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age |
| Devit-3 Oral Drop 800 IU | Active comparator | Drug: Devit-3 Oral DropDevit-3 Oral Drop 800 IU once daily by oral route started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age |
| Devit-3 Oral Drop 1000 IU | Active comparator | Drug: Devit-3 Oral DropDevit-3 Oral Drop1000 IU once daily by oral route started when achieved 75%of total nutrition by enteral feedings and continued until 36 weeks postmenstrual age |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants with gestational age 24 to 32 weeks who achieved at least 75% of total nutrition by enteral feedings in postnatal 2 weeks
Key exclusion criteria (4 listed)
- perinatal asphyxia,
- major congenital or chromosomal anomalies,
- those with no expectation of survival in first 2 weeks
- those that total parenteral nutrition was not ceased by the first 2 weeks
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 |
|---|---|---|
| Devit-3 Oral Drop | Drug | Devit-3 Oral Drop 1000 IU, Devit-3 Oral Drop 400 IU, Devit-3 Oral Drop 800 IU |
Primary outcome
Serum concentration of 25(OH) D at 36 weeks postmenstrual age.
Time frame: 36 weeks
Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.
Time frame: 36 weeks
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 6 Feb 2017.
- 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.
- Derived from this study: PubMed 28779655Bozkurt O, Uras N, Sari FN, Atay FY, Sahin S, Alkan AD, Canpolat FE, Oguz SS. Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses. Early Hum Dev. 2017 Sep;112:54-59. doi: 10.1016/j.earlhumdev.2017.07.016. Epub 2017 Aug 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Devit-3 Oral Drop in people with Vitamin D Deficiency and Preterm Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 6 Feb 2017. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum concentration of 25(OH) D at 36 weeks postmenstrual age. (time frame: 36 weeks). The study lists 2 primary outcomes in all. 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 NCT02941185, which also lists 2 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 6 Feb 2017.