Vitamin D Status and Dose Response in Infants

Prematurity Clinical Trial

Official title:

Vitamin D Status and Dose Response in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042561
• Other study ID #: 0281-09-FB
• Status: Completed
• Phase: N/A
• Start date: August 7, 2009
• Est. completion date: August 1, 2010

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 1, 2010
• Est. primary completion date: August 1, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Minutes to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Prematurity
• Vitamin D

Intervention

Dietary Supplement:
• Vitamin D3
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
• vitamin D3 placebo
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Creighton University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25-Hydroxyvitamin D [25(OH)D] Levels	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	Serum C-reactive protein (CRP)	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
Secondary	Serum intact parathyroid hormone (iPTH)	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