Vitamin D Status and Dose Response in Infants

August 29, 2023 updated by: University of Nebraska
This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is hypothesized that serum 25(OH)D levels in infants 32 weeks and greater gestation are not maintained at optimal levels of greater than 32 ng/Ml with currently available infant formulas, and that this will have an inverse relationship with markers of inflammation and bone metabolism.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 minutes to 3 months (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • greater than 32 weeks gestation,
  • exclusively formula fed.

Exclusion Criteria:

  • less than 32 weeks gestation,
  • less than 1500 grams,
  • recieving maternal breast milk,
  • recieving parenteral nutrition,
  • congenital anomolies,
  • disorders of vitamin D metabolism,
  • inborn errors of metabolism,
  • seizure disorders,
  • parathroid disease,
  • liver, GI tract, or kidney disease, and
  • disorders of calcium metabolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
This group will recieve the current standard of care for infants in the NICU, recieving infant formula that provides less than 400 IU of vitamin D a day.
Dietary supplement: vitamin D3 placebo
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
Experimental: Vitamin D
This group will recieve standard of care infant formulas that provide less than 400 IU of vitamin D a day, in addition they will be supplemented with 400 IU of vitamin D3 daily.
Dietary supplement: Vitamin D3
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
Other Names:
  • DVi-Sol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum 25-Hydroxyvitamin D [25(OH)D] Levels
Time Frame: 30 days
Total serum 25(OH)D level is currently considered the best indicator of vitamin D supply to the body from cutaneous synthesis and nutritional intake. For infants, ≤37.5 nmol/L (15 ng/mL) would be considered indicative of deficiency and >50 nmol/L (20 ng/mL) as indicative of vitamin D sufficiency.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum C-reactive protein (CRP)
Time Frame: 30 days
Serum C-reactive protein (CRP) is a protein made by the liver and increases when there's inflammation in the body. The upper normal reference levels range from 6 to 20 mg/L as cutoff levels to indicate the presence of sepsis or infection.
30 days
Serum intact parathyroid hormone (iPTH)
Time Frame: 30 days
Secretion of parathyroid hormone (PTH) is regulated by the level of calcium in the blood. Low serum calcium causes increased PTH to be secreted, whereas increased serum calcium inhibits PTH release. Normal values are 10 to 55 picograms per milliliter (pg/mL).
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Creighton University Medical Center

Investigators

  • Principal Investigator: Corrine Hanson, PhD, RD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

December 31, 2009

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimated)

January 5, 2010

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0281-09-FB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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