Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants

NCT01469650 | Completed

• 1 other identifier: 0419-11-FB
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine levels of vitamin D supplementation to achieve goal serum 25-hydroxy vitamin D \[25(OH)D\] levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in Newborn Intensive Care Nursery (NICU). Infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day.

Conditions

Premature Infants

Keywords

vitamin D3; prematurity; parathyroid hormone; 25(OH)D; NICU hospitalization

Outcome Measures

Primary Outcomes (1)

• Serum 25-hydroxy vitamin D [25(OH)D] Levels

  Serum 25-hydroxy vitamin D \[25(OH)D\] levels will be compared between the two groups, vitamin D supplementation of 400 IU vitamin D3/day, or 800 IU vitamin D3/day. The specific aims of this study are to determine leves of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL.

  1 year

Secondary Outcomes (1)

• Parathyroid Hormone Levels

  1 year

Study Arms (2)

400 IU/day vitamin D

ACTIVE COMPARATOR

Subjects will receive 400 IU/day of vitamin D3, as per current unit policy

Dietary Supplement: cholecalciferal

800 IU/day vitamin D3

EXPERIMENTAL

Subjects will receive 800 IU/day vitamin D3

Dietary Supplement: cholecalciferol

Interventions

cholecalciferal DIETARY_SUPPLEMENT

400 IU/day

Also known as: vitamin D3

400 IU/day vitamin D

cholecalciferol DIETARY_SUPPLEMENT

800 IU/day D3

Also known as: vitamin D3

800 IU/day vitamin D3

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• NICU hospitalized infants
• weeks gestation

You may not qualify if:

• congential anomalies
• disorders of calcium metabolism
• inborn error of metabolism
• kidney disease
• liver disease
• use of steroids

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

• Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

  PMID: 33305842 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Corrine K Hanson, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 10, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

US (1)