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Multi-dose Vitamin D Supplementation in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02941185
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ozlem Bozkurt, MD, Zekai Tahir Burak Women's Health Research and Education Hospital

Tracking Information
First Submitted Date  ICMJE October 18, 2016
First Posted Date  ICMJE October 21, 2016
Last Update Posted Date February 6, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-dose Vitamin D Supplementation in Preterm Infants
Official Title  ICMJE Not Provided
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Vitamin D Deficiency
  • Preterm Infants
Intervention  ICMJE Drug: Devit-3 Oral Drop
Study Arms  ICMJE
  • Devit-3 Oral Drop 400 IU
    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
    Intervention: Drug: Devit-3 Oral Drop
  • Active Comparator: Devit-3 Oral Drop 800 IU
    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
    Intervention: Drug: Devit-3 Oral Drop
  • Active Comparator: Devit-3 Oral Drop 1000 IU
    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
    Intervention: Drug: Devit-3 Oral Drop
Publications * Bozkurt 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2017)
121
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2016)
120
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Preterm infants with gestational age 24 to 32 weeks who achieved at least 75% of total nutrition by enteral feedings in postnatal 2 weeks

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Weeks to 32 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02941185
Other Study ID Numbers  ICMJE ZTB2015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ozlem Bozkurt, MD, Zekai Tahir Burak Women's Health Research and Education Hospital
Study Sponsor  ICMJE Zekai Tahir Burak Women's Health Research and Education Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Zekai Tahir Burak Women's Health Research and Education Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP