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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01363167
Other study ID # HR# 17217
Secondary ID K23RR021891
Status Completed
Phase N/A
First received April 18, 2011
Last updated November 21, 2014
Start date October 2011
Est. completion date October 2013

Study information

Verified date November 2014
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Days
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Dietary Supplement:
400 IU Cholecalciferol- Vitamin D Daily
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.

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina
United States Medical University of South Carolina Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intestinal Calcium Absorption When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth No
Primary Parathyroid hormone concentration At term age (expected 2-4 months) No
Primary Serum 25 hydroxyvitamin D status At term age (expected 2-4 months) Yes
Primary Bone Health 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. At term age (expected 2-4 months) No
Primary Serum inflammatory cytokine concentrations At birth (day 1) No
Secondary Phosphorus Homeostasis Measurement of serum and urine phosphorus concentrations At term age (expected 2-4 months) No
Secondary Growth parameters At term age (expected 2-4 months) No
Secondary Vitamin D Dose Safety as Measured by Urinary Calcium Excretion At term age (expected 2-4 months) Yes
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