Study to Assess the Use of a Simple Lab Test to Screen for Rickets in Children
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/1/2014 |
| Start Date: | June 2006 |
| End Date: | July 2007 |
| Contact: | James A Taylor, MD |
| Email: | uncjat@u.washington.edu |
| Phone: | (206) 616-1206 |
The Feasibility of Assessing the Prevalence of Rickets in Children
Some experts recommend that all breastfed babies receive supplemental vitamin D. The
purpose of this study is to determine the rate of vitamin D use in breastfed babies, the
recommendations of pediatricians regarding vitamin D, and the impact on these
recommendations on parental choice of vitamin D. In addition, in preparation for a large
study to see how many breastfed children who don't receive supplemental vitamin D have
rickets, in this study we will determine if a simple blood test, an alkaline phosphatase
level, could be used to screen for rickets. Parents of children 6-23 months old are
eligible to complete feeding surveys and children 6-15 months old who were breastfed for at
least the first six months of life and didn't routinely receive vitamin D are eligible for
alkaline phosphatase levels. We postulate that most breastfed babies don't receive
supplemental vitamin D, and that alkaline phosphatase levels will only be abnormal in a few
babies who will have evidence on x-ray of rickets.
purpose of this study is to determine the rate of vitamin D use in breastfed babies, the
recommendations of pediatricians regarding vitamin D, and the impact on these
recommendations on parental choice of vitamin D. In addition, in preparation for a large
study to see how many breastfed children who don't receive supplemental vitamin D have
rickets, in this study we will determine if a simple blood test, an alkaline phosphatase
level, could be used to screen for rickets. Parents of children 6-23 months old are
eligible to complete feeding surveys and children 6-15 months old who were breastfed for at
least the first six months of life and didn't routinely receive vitamin D are eligible for
alkaline phosphatase levels. We postulate that most breastfed babies don't receive
supplemental vitamin D, and that alkaline phosphatase levels will only be abnormal in a few
babies who will have evidence on x-ray of rickets.
The Puget Sound Pediatric Research Network (PSPRN) is a practice-based research network of
pediatricians in the Puget Sound area and at the University of Washington and Children’s
Hospital and Regional Medical Center. The network has extensive experience in conducting
large studies on contentious issues that are pertinent to children, their parents, and
primary care providers. In 2004, vitamin D supplementation was recommended for all
exclusively breastfed infants. This recommendation was based on sporadic reports over the
last 30 years of vitamin D deficient rickets in infants and toddlers who have been
exclusively breastfed. The recommendation has been controversial because it might undermine
efforts to promote breastfeeding, and because the prevalence of rickets in these patients is
unknown. PSPRN proposes to conduct a preliminary study to determine the feasibility of a
larger planned project by the network to determine the prevalence of rickets in breastfed
infants and toddlers who do not receive supplemental vitamin D. Systematic surveys will be
conducted in PSPRN practices to determine current levels and trends in vitamin D
supplementation. Current practices of PSPRN pediatricians regarding supplementation, and
their effect on parents, will also be assessed. The utility of a serum alkaline phosphatase
level as a screening test for vitamin D deficient rickets will be determined in the proposed
study by obtaining levels on approximately 300 patients, 6-15 months old, seen by PSPRN
practitioners, who have been breastfed. In addition to assessing possible methodologies
for the larger project, the preliminary study is designed to yield standalone results with
important implications.
pediatricians in the Puget Sound area and at the University of Washington and Children’s
Hospital and Regional Medical Center. The network has extensive experience in conducting
large studies on contentious issues that are pertinent to children, their parents, and
primary care providers. In 2004, vitamin D supplementation was recommended for all
exclusively breastfed infants. This recommendation was based on sporadic reports over the
last 30 years of vitamin D deficient rickets in infants and toddlers who have been
exclusively breastfed. The recommendation has been controversial because it might undermine
efforts to promote breastfeeding, and because the prevalence of rickets in these patients is
unknown. PSPRN proposes to conduct a preliminary study to determine the feasibility of a
larger planned project by the network to determine the prevalence of rickets in breastfed
infants and toddlers who do not receive supplemental vitamin D. Systematic surveys will be
conducted in PSPRN practices to determine current levels and trends in vitamin D
supplementation. Current practices of PSPRN pediatricians regarding supplementation, and
their effect on parents, will also be assessed. The utility of a serum alkaline phosphatase
level as a screening test for vitamin D deficient rickets will be determined in the proposed
study by obtaining levels on approximately 300 patients, 6-15 months old, seen by PSPRN
practitioners, who have been breastfed. In addition to assessing possible methodologies
for the larger project, the preliminary study is designed to yield standalone results with
important implications.
Inclusion Criteria:
- Predominantly breastfed for first 6 months of life
- No routine use of vitamin D during first six months of life
- Singleton birth
- Birth at > 35 weeks gestation
Exclusion Criteria:
- Formula fed
- Significant formula supplementation
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