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Completed

NCT Number: NCT01363167

Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2

This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.

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Key information

Conditions

Infant, Very Low Birth Weight Avitaminosis Calcium Deficiency Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

1 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina, Charleston, South Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any infant born at the Medical University of South Carolina <34 weeks gestation
  • Less that 1500g at birth
  • AGA
  • Must be African American or Caucasian
  • Each infant born of twin and triplet pregnancies will be eligible

Exclusion criteria

  • Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion
  • Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA)
  • Maternal uncontrolled thyroid disease
  • Maternal Parathyroid disease
  • Infants of races other than African American or Caucasian

Treatment and study plan

400 IU Cholecalciferol- Vitamin D Daily

Dietary Supplement

Infants who are defined as vitamin D deficient at birth will be randomized to receive either 400 IU vitamin D/day or placebo daily until term age is reached.

Primary outcomes

  1. Intestinal Calcium Absorption

    Time frame: When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth

  2. Parathyroid hormone concentration

    Time frame: At term age (expected 2-4 months)

  3. Serum 25 hydroxyvitamin D status

    Time frame: At term age (expected 2-4 months)

  4. Bone Health

    Time frame: At term age (expected 2-4 months)

    Bone ultrasound measurement, serum alkaline phosphatase, and bone-specific alkaline phosphatase at birth and monthly until term age. Bone mineralization by DEXA scan at hospital discharge and term age.

  5. Serum inflammatory cytokine concentrations

    Time frame: At birth (day 1)

Secondary outcomes

  1. Phosphorus Homeostasis

    Time frame: At term age (expected 2-4 months)

    Measurement of serum and urine phosphorus concentrations

  2. Growth parameters

    Time frame: At term age (expected 2-4 months)

  3. Vitamin D Dose Safety as Measured by Urinary Calcium Excretion

    Time frame: At term age (expected 2-4 months)

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

Identifying Vit D Deficiency in VLBW Infants Part 2

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 1, 2011
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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