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| Name | Class |
|---|---|
| Creighton University Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | 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. |
|
| Vitamin D | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | 400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corrine Hanson, PhD, RD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33305842 | Derived | Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| vitamin D3 placebo | Dietary Supplement | Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 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). |
| 30 days |
| D000091642 | Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |