Clincosm LogoSign in Get a demo

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

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT01793402
Collaborator
(none)
120
Enrollment
1
Location
20
Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Adequacy of Vitamin D Intake and Vitamin D Status in Early Preterm Infants
    Study Start Date :
    Oct 1, 2010
    Actual Primary Completion Date :
    May 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Preterm infants born at or less than 32 weeks gestation

    Outcome Measures

    Primary Outcome Measures

    1. Serum 25-hydroxyvitamin-D concentration at the time of birth and at discharge from the hospital. [6 weeks]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 1 Week
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cincinnati Medical Center Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati

    Investigators

    • Study Director: Henry T Akinbi, M.D., Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Henry Akinbi, Associate Professor, Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT01793402
    Other Study ID Numbers:
    • VitD_Preterm#1
    First Posted:
    Feb 15, 2013
    Last Update Posted:
    Apr 19, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Rickets
    Avitaminosis
    Vitamin D Deficiency

    Study Results

    No Results Posted as of Apr 19, 2013