Vitamin D, Prematurity
Conditions
Keywords
vitamin d, prematurity, 25(OH)D, infant, CRP, PTH
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.
Interventions
DIETARY_SUPPLEMENTVitamin D3
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
DIETARY_SUPPLEMENTvitamin D3 placebo
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
Sponsors
Creighton University Medical Center
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Minutes to 3 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed