Clinical trial NCT01793402: Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants
Official title: Adequacy of Vitamin D Intake and Vitamin D Status in Early Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovitaminosis D
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All infants born at or less than 32 weeks postmenstrual age admitted to the Newborn Intensive Care Unit at University of Cincinnati Medical Center were eligible. Intake of vitamin D and serum 25-hydroxyvitamin-D concentrations were assessed during stay in the Newborn Intensive Care Unit.

Brief summary: Vitamin D is an essential nutrient. Deficiency of vitamin D is widespread. The prevalence of vitamin D deficiency in early preterm infants is unknown. The American Academy of Pediatrics recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D. This study assesses vitamin D status at birth and during hospital stay in infants delivered delivered at earlier than or at 32 weeks gestation. We also assess the adequacy of intake relative to the target set by the American Academy of Pediatrics for children.

Detailed description: Vitamin D is important for bone health. Deficiency of vitamin D is widespread and is associated with a variety of diseases. Preterm infants are susceptible osteopenia of prematurity (OP). Vitamin D deficiency may contribute to OP. The American Academy of Pediatrics (AAP) recommends a daily intake of 400 IU in order to achieve a serum concentration of 20 ng/ml of vitamin D. This recommendation presumes exposure to sunlight, the best source of vitamin D. Whether this level of intake or target serum concentration are achieved in early preterm infants is unknown. We hypothesize that because early preterm infants are sequestered in the Newborn Intensive Care Units for an extended period of time, they will be deficient in vitamin D and that the current nutritional intake may not be adequate in meeting the AAP recommendation. We assessed the concentration of serum 25-hydroxyvitamin-D in parturient mothers and in their newborns if they were less than 32 week gestation. We monitored vitamin D intake during hospitalization in the Newborn Intensive Care Unit and serum 25-hydroxyvitamin-D at discharge.

Eligibility criteria: Inclusion Criteria:

* All neonates delivered at or less than 32 weeks gestation were eligible.

Exclusion Criteria:

* Infants with lethal congenital malformation
* Infants that were not expected to survive to discharge
* Infants delivered from multiple gestation

Primary outcomes:
measure: Serum 25-hydroxyvitamin-D concentration at the time of birth and at discharge from the hospital.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Henry T Akinbi, M.D.
role: STUDY_DIRECTOR
References: