Impact of Vitamin D Status on Bones in Breastfed Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00697294
Recruitment Status : Completed
First Posted : June 13, 2008
Last Update Posted : December 5, 2011
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Tri-Vi-Sol Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vitamin D Status and Impact on Bone Mineralization in Human Milk Fed Hispanic and Caucasian Infants
Study Start Date : July 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine if infant vitamin D status is related to bone mineral status at birth [ Time Frame: End of study ]
  2. 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 ]

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Ages Eligible for Study:   up to 2 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00697294

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
Principal Investigator: Steven A Abrams, MD Baylor College of Medicine


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine Identifier: NCT00697294     History of Changes
Other Study ID Numbers: H-22293
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: December 5, 2011
Last Verified: December 2011

Keywords provided by Steve Abrams, MD, Baylor College of Medicine:
Vitamin D deficiency
Breast feeding

Additional relevant MeSH terms:
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents