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

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ClinicalTrials.gov Identifier: NCT01793402
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Henry Akinbi, Children's Hospital Medical Center, Cincinnati

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
Hypovitaminosis D

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.

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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 : October 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort
Preterm infants born at or less than 32 weeks gestation



Primary Outcome Measures :
  1. Serum 25-hydroxyvitamin-D concentration at the time of birth and at discharge from the hospital. [ Time Frame: 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.



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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793402


Locations
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United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Study Director: Henry T Akinbi, M.D. Children's Hospital Medical Center, Cincinnati

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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: February 15, 2013    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Rickets
Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents