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Clinical Trials/NCT00697294
NCT00697294CompletedNot Applicable

Vitamin D Status and Impact on Bone Mineralization in Human Milk Fed Hispanic and Caucasian Infants

Baylor College of Medicine3 sites in 1 country80 target enrollmentStarted: July 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
3
Primary Endpoint
To evaluate the relative frequency of vitamin D deficiency in human milk fed Hispanic compared to Caucasian newborn infants in Houston, Texas.

Study Overview

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.

Detailed Description

In recent years, severe vitamin D deficiency has resurfaced as a major public health concern. Nutritional rickets is widespread, and a recent report on this disease in Texas showed Hispanic children are at increased risk. Long-term follow-up has demonstrated that vitamin D deficient infants are more likely to have decreased bone mineral status in late childhood. Additionally, vitamin D deficiency has been linked to changes in fetal "imprinting" and increased susceptibility to autoimmune diseases, immune deficiency, and malignancy. At birth, an infant's vitamin D status is entirely dependent on the vitamin D status of the mother. Many studies have shown vitamin D deficiency is very common in mother-child pairs, especially in dark-skinned individuals. However, few data exist regarding the vitamin D status in Hispanic infants. Low milk intakes and decreased sun exposure with urbanization makes this a very high-risk group among infants in Texas.

Potential subjects will be identified by study personnel in labor and delivery at St. Luke's and Ben Taub Hospitals and in the normal newborn nurseries. The parent/guardian will be approached and the study will be explained in full. A time for questions will be allowed. Once the parent/guardian agrees to his/her child's participation, an informed written consent form will be signed. Subject confidentiality will be maintained within limits of the law. All names and personal information will be accessed only by the investigators and authorized personnel. There will be no possibility of coercion as subjects will not have any relationship of dependency with the investigators.

A cohort of Hispanic and Caucasian infants will be recruited and followed. Other ethnic groups will not be excluded, but will not be analyzed in terms of the primary outcome. Race and ethnicity will be classified according to mother's self classification. The interventions will not differ between the groups.

This study includes 3 study visits:

  1. Baseline inpatient visit at birth - while hospitalized to obtain consent, obtain cord blood sample, and mother to complete a questionnaire
  2. 1 week after initial hospital discharge - first outpatient visit to obtain other baseline data (see below) and to start the vitamin D drops
  3. At 3 mo of life - second outpatient visit to obtain final data (see below) and discontinue vitamin D drops

Study Design

Study Type
Interventional
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
— to 2 Hours (Child)
Sex
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

Arms & Interventions

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.

Intervention: Tri-Vi-Sol (Dietary Supplement)

Outcomes

Primary Outcomes

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 Outcomes

  • To determine if infant vitamin D status is related to bone mineral status at birth(End of study)
  • 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.(End of study)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Steve Abrams, MD

Professor

Baylor College of Medicine

Study Sites (3)

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