Impact of Vitamin D Status on Bones in Breastfed Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00697294
First received: June 3, 2008
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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
Vitamin D Deficiency
Dietary Supplement: Tri-Vi-Sol

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Vitamin D Status and Impact on Bone Mineralization in Human Milk Fed Hispanic and Caucasian Infants

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • To evaluate the relative frequency of vitamin D deficiency in human milk fed Hispanic compared to Caucasian newborn infants in Houston, Texas. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if infant vitamin D status is related to bone mineral status at birth [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To determine the effects of vitamin D supplementation on 25-hydroxyvitamin D (25-OHD) concentration and bone mineral status vitamin D deficient and vitamin D replete infants at 3 months of age. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2008
Study Completion Date: November 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supplement
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.
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.
Other Name: ADC drops

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  Eligibility

Ages Eligible for Study:   up to 2 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Full term infants (37-42 weeks)
  • Appropriate for gestational age
  • Free of major congenital anomalies
  • Born to mothers without a history of diabetes or chronic illness who intend to exclusively breastfeed

Exclusion Criteria:

  • Any child who does not meet the above inclusion criteria
  • Insufficient cord blood available to determine cord 25-hydroxyvitamin D status
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697294

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Ben Taub General Hospital
Houston, Texas, United States, 77030
St Lukes Episcopal Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Steven A Abrams, MD Baylor College of Medicine
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00697294     History of Changes
Other Study ID Numbers: H-22293
Study First Received: June 3, 2008
Last Updated: December 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Vitamin D deficiency
Infants
Breast feeding

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 29, 2014