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

NCT01793402 | Completed

• 1 other identifier: VitD_Preterm#1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovitaminosis D

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Preterm infants born at or less than 32 weeks gestation

Eligibility Criteria

• Age: 1 Day - 1 Week
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Henry T Akinbi, M.D.

  Children's Hospital Medical Center, Cincinnati

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

US (1)