Vitamin D Status and Dose Response in Infants

Not Applicable

Completed

• Conditions: Prematurity; Vitamin D
• Interventions: Dietary Supplement: vitamin D3 placebo; Dietary Supplement: Vitamin D3

• Registration Number: NCT01042561
• Lead Sponsor: University of Nebraska

Brief Summary

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.

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 Timeline

• Study Start: 2009-08-07
• Study First Submitted: 2009-12-31
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2010-08-01
• Study Completion: 2010-08-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	vitamin D3 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.
Vitamin D	Vitamin D3	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.

Primary Outcome Measures

Name	Time	Method
Serum 25-Hydroxyvitamin D [25(OH)D] Levels	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.

Secondary Outcome Measures

Name	Time	Method
Serum C-reactive protein (CRP)	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.
Serum intact parathyroid hormone (iPTH)	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).

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States