Multi-dose Vitamin D Supplementation in Preterm Infants

Study Overview
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Brief Summary
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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
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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
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Vitamin D Deficiency, Preterm Infants

Intervention / Treatment
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* Drug: Devit-3 Oral Drop


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Devit-3 Oral Drop 400 IU<br>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<br> <br> |
| Active Comparator: Devit-3 Oral Drop 800 IU<br>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<br> <br> |
| Active Comparator: Devit-3 Oral Drop 1000 IU<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |