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Multi-dose Vitamin D Supplementation in Preterm Infants

Primary Purpose

Vitamin D Deficiency, Preterm Infants

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Devit-3 Oral Drop
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency

Eligibility Criteria

24 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zekai Tahir Burak Women's Health and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Devit-3 Oral Drop 400 IU

Devit-3 Oral Drop 800 IU

Devit-3 Oral Drop 1000 IU

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Serum concentration of 25(OH) D at 36 weeks postmenstrual age.
Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.

Secondary Outcome Measures

Full Information

First Posted
October 18, 2016
Last Updated
February 3, 2017
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02941185
Brief Title
Multi-dose Vitamin D Supplementation in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Preterm Infants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Devit-3 Oral Drop 400 IU
Arm Type
Other
Arm Description
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
Arm Title
Devit-3 Oral Drop 800 IU
Arm Type
Active Comparator
Arm Description
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
Arm Title
Devit-3 Oral Drop 1000 IU
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Devit-3 Oral Drop
Primary Outcome Measure Information:
Title
Serum concentration of 25(OH) D at 36 weeks postmenstrual age.
Time Frame
36 weeks
Title
Prevalence of vitamin D deficiency at 36 weeks postmenstrual age.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Zekai Tahir Burak Women's Health and Education Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
33305842
Citation
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.
Results Reference
derived
PubMed Identifier
28779655
Citation
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.
Results Reference
derived

Learn more about this trial

Multi-dose Vitamin D Supplementation in Preterm Infants

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