Vitamin D Status and the Adequacy of Vitamin D Intake in Early Preterm Infants

Hypovitaminosis D Clinical Trial

Official title:

Adequacy of Vitamin D Intake and Vitamin D Status in Early Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793402
• Other study ID #: VitD_Preterm#1
• Status: Completed
• Phase: N/A
• First received: February 13, 2013
• Last updated: April 17, 2013
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: April 2013
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 1 Week

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Avitaminosis
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25-hydroxyvitamin-D concentration at the time of birth and at discharge from the hospital.	This is a longitudinal study that assessed vitamin D status at birth in infants as well as in their mothers. Daily intake of vitamin D was analyzed. The serum concentration of 25-hydroxyvitamin-D at discharge was assessed. We correlated maternal vitamin D with infants' vitamin D concentrations at birth. We also correlated vitamin D concentration at birth with the concentration at discharge.	6 weeks	No