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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00697294 |
Vitamin D deficiency is widespread and linked to decreased bone mineral content. Little data exists regarding the vitamin D status and the relationship of 25-hydroxyvitamin D (25-OHD) status to functional bone health outcomes in Hispanic infants. To evaluate this, we plan an observational cohort of full term, healthy, exclusively breastfed Hispanic and Caucasian infants. We hypothesize serum 25-OHD measured in cord blood will be significantly lower in Hispanic than Caucasian infants, with 25-OHD less than 20 ng/mL found in at least 50% of Hispanic neonates. Secondary aims evaluate the relationship between 25-OHD levels and bone mineral status at baseline and after 3 months of 400 IU/day supplemental vitamin D3. Whole body bone density scan (DXA) and bone ultrasound (SOS U/S) will be measured shortly after birth, then again after supplementation. Data from this study will provide information needed to design further randomized trials and interventions.
Condition | Intervention |
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Vitamin D Deficiency |
Dietary Supplement: Tri-Vi-Sol |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Vitamin D Status and Impact on Bone Mineralization in Human Milk Fed Hispanic and Caucasian Infants |
Estimated Enrollment: | 60 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Supplement: Experimental
Subjects will serve as their own control in this single-arm protocol. All subjects will receive 400 IU/day of vitamin D as the intervention. Comparisons will be made between Caucasian and Hispanic infants.
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Dietary Supplement: Tri-Vi-Sol
All subjects will begin vitamin D supplementation at the first outpatient visit (at 1 week of life) and will continue through the second outpatient visit (at 3 months of age). Dosage will be 400 IU/day of vitamin D in the form of Tri-Vi-Sol vitamin drops.
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Ages Eligible for Study: | up to 2 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stefanie P Rogers, MD | 713-798-6707 | spr@bcm.edu |
Contact: Keli M Hawthorne, MS, RD | 713-798-7085 | kelih@bcm.edu |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Stefanie P Rogers, MD 713-798-6707 spr@bcm.edu | |
Contact: Keli M Hawthorne, MS, RD 713-798-7085 kelih@bcm.edu | |
Principal Investigator: Steven A Abrams, MD | |
Sub-Investigator: Stefanie P Rogers, MD | |
Sub-Investigator: Keli M Hawthorne, MS, RD | |
Ben Taub General Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Stefanie Rogers, MD 713-798-6707 spr@bcm.edu | |
St Lukes Episcopal Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Stefanie Rogers, MD 713-798-6707 spr@bcm.edu |
Principal Investigator: | Steven A Abrams, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Steve Abrams, MD ) |
Study ID Numbers: | H-22293 |
Study First Received: | June 3, 2008 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00697294 |
Health Authority: | United States: Institutional Review Board |
Vitamin D deficiency Infants Breast feeding |
Vitamin D Deficiency Cholecalciferol Vitamin D Malnutrition |
Avitaminosis Ergocalciferols Nutrition Disorders Deficiency Diseases |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |