Multi-dose Vitamin D Supplementation in Preterm Infants
1 other identifier
interventional
121
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 18, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 6, 2017
February 1, 2017
2.9 years
October 18, 2016
February 3, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Serum concentration of 25(OH) D at 36 weeks postmenstrual age.
36 weeks
Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.
36 weeks
Study Arms (3)
Devit-3 Oral Drop 400 IU
OTHERsupplemented 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 COMPARATORDevit-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 COMPARATORDevit-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
Interventions
Eligibility Criteria
You may qualify if:
- Preterm infants with gestational age 24 to 32 weeks who achieved at least 75% of total nutrition by enteral feedings in postnatal 2 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zekai Tahir Burak Women's Health and Education Hospital
Ankara, 06230, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 33305842DERIVEDBozkurt 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.
PMID: 28779655DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neonatology fellow
Study Record Dates
First Submitted
October 18, 2016
First Posted
October 21, 2016
Study Start
January 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 6, 2017
Record last verified: 2017-02