Vitamin D Status and Dose Response in Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vitamin D Status and Dose Response in Infants

Conditions
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Vitamin D, Prematurity

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: vitamin D3 placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Minutes
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>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. | Dietary Supplement: vitamin D3 placebo<br>* Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.<br>|
| Experimental: Vitamin D<br>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. | Dietary Supplement: Vitamin D3<br>* 400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.<br>* Other names: DVi-Sol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin d, prematurity, 25(OH)D, infant, CRP, PTH