Vitamin D Status and Dose Response in Infants
|ClinicalTrials.gov Identifier: NCT01042561|
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : November 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Prematurity||Dietary Supplement: Vitamin D3 Dietary Supplement: vitamin D3 placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Vitamin D Status and Dose Response in Infants|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
Placebo Comparator: placebo
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
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
Experimental: Vitamin d
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
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
Other Name: DVi-Sol
- serum 25(OH)D levels [ Time Frame: 30 days ]
- serum C-reactive protein (CRP) [ Time Frame: 30 days ]
- serum intact parathyroid hormone (iPTH) [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042561
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|