Vitamin D Status and Dose Response in Infants

University of Nebraska

Status: Completed

Conditions: Prematurity; Vitamin D

Treatments: Dietary Supplement: vitamin D3 placebo; Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01042561

0281-09-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 5 minutes to 3 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: vitamin D3 placebo

Vitamin D

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin D3