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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

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Preterm Infants Drug: Devit-3 Oral Drop Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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
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
Drug: Devit-3 Oral Drop



Primary Outcome Measures :
  1. Serum concentration of 25(OH) D at 36 weeks postmenstrual age. [ Time Frame: 36 weeks ]
  2. Prevalence of vitamin D deficiency at 36 weeks postmenstrual age. [ Time Frame: 36 weeks ]


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Ages Eligible for Study:   24 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941185


Locations
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Turkey
Zekai Tahir Burak Women's Health and Education Hospital
Ankara, Turkey, 06230
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ozlem Bozkurt, MD, Neonatology fellow, Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02941185    
Other Study ID Numbers: ZTB2015
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Premature Birth
Vitamin D Deficiency
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents