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| ID | Type | Description | Link |
|---|---|---|---|
| K23RR021891 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 IU Cholecalciferol - Vitamin D | Active Comparator |
| |
| Placebo | Placebo Comparator | Placebo contains Fractionated Coconut Oil |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 400 IU Cholecalciferol- Vitamin D Daily | Dietary Supplement | Infants who are defined as vitamin D deficient at birth will be randomized to receive either 400 IU vitamin D/day or placebo daily until term age is reached. |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal Calcium Absorption | When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth | |
| Parathyroid hormone concentration | At term age (expected 2-4 months) | |
| Serum 25 hydroxyvitamin D status | At term age (expected 2-4 months) | |
| Bone Health | Bone ultrasound measurement, serum alkaline phosphatase, and bone-specific alkaline phosphatase at birth and monthly until term age. Bone mineralization by DEXA scan at hospital discharge and term age. | At term age (expected 2-4 months) |
| Serum inflammatory cytokine concentrations | At birth (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphorus Homeostasis | Measurement of serum and urine phosphorus concentrations | At term age (expected 2-4 months) |
| Growth parameters | At term age (expected 2-4 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah N. Taylor, M.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425-8750 | United States | ||
| Medical University of South Carolina |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| Vitamin D Dose Safety as Measured by Urinary Calcium Excretion | At term age (expected 2-4 months) |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| D009750 |
| Nutritional and Metabolic Diseases |