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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Vitamin D Deficiency; Calcium Deficiency; Infant, Very Low Birth Weight

Treatments: Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01363167

HR# 17217

K23RR021891 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

400 IU Cholecalciferol - Vitamin D

Active Comparator group

Treatment:

Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily

Placebo

Placebo Comparator group

Description:

Placebo contains Fractionated Coconut Oil

Treatment:

Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily