Vitamin D Status and Dose Response in Infants

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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