# Presentation: 209853

## Vitamin D supplementation for breastfed infants

- Puget Sound Pediatric Research Network
- Jim Taylor, MD
- University of Washington

## Acknowledgment

- Funding for the study provided by the
- Agency for Healthcare Research and Quality

## Background

- 2003 AAP recommended vitamin D supplementation for all breastfed infants
- No data on incidence
- Concern that recommending vitamin D might decrease breastfeeding
- Idea for study
- Assess parental/pediatrician practices
- Attempt to identify a method for screening for large incidence study

## Methods

- Study conducted by PSPRN
- 7 private pediatric practices, 1 inner-city pediatric clinic
- Seattle area

## Methods

- 3 components to study
- Survey on vitamin D recommendation by PSPRN pediatricians
- Survey of parents of young children seen in PSPRN offices
- Alkaline phosphatase determination on a convenience sample of children

## Physician survey

- Current vitamin D recommendation practice
- Indicated level of agreement with statements about supplementation
- Important to follow guidelines
- Recommendation not evidence-based
- Recommendation may lead to less breastfeeding
- Some babies may develop rickets if not given vitamin D

## Parent survey

- Completed by parents of children 6-23 months old seen in PSPRN office
- Administered by research assistant
- Distributed by office staff during multiple 2-4 week blocks

## Parent survey

- Child’s age
- Child’s pediatrician
- Feeding type in first month
- Length of breastfeeding
- Routine supplementation
- Maximal supplementation
- Routine use of multivitamins

## Parent survey

- Likert scale response to statements about vitamins/rickets
- Vitamins important for healthy babies
- Vitamins needed to prevent rickets or other diseases
- Inconvenient to give vitamins to young babies

## Parent survey

- Likert scale response to statements about vitamins/rickets
- Babies don’t need vitamins because breastmilk/formula has everything needed
- Don’t need vitamins if babies are out in sunlight and fresh air
- My child’s doctor recommended that I give baby vitamins

## Alkaline phosphatase (AP) levels

- In published reports of vitamin D deficient rickets in breastfed infants, 92-99% of children had elevated AP at diagnosis
- Requires 0.1 ml serum
- Low cost
- May be good screen for rickets, specificity unknown

## AP levels

- AP levels obtained on children 6-15 months old
- breastfed for 6+ months
- minimal supplementation
- No routine use of vitamin D
- Recruited patients who were having blood obtained for clinical purpose (usually screening hematocrit)

## AP levels

- Blood transported to UW lab
- Sample tested within 4 hours
- High AP:  > 281 in girls, >324 boys
- Patients with high AP levels offered radiograph to diagnose/rule out rickets
- 1 view wrist, knee
- Radiographs read by single peds radiologist

## Analysis: Physician survey

- Outcome:  current vitamin D recommendation practice

## Analysis: Parent survey

- Main outcome: use of vitamin D in eligible children
- Breastfed for 6+ months
- < 8 oz formula daily on routine basis
- “Never” or “rarely” given 16+ oz formula in a day during first 6 months

## Analysis: Parent survey

- Compare eligible children who received, or didn’t receive routine vitamin D supplementation
- Patient demographics
- Parental health beliefs
- Vitamin D recommendation practice of pediatrician
- Account for clustering into practices

## Interim, preliminary results:Physician survey

- 41 responding PSPRN pediatricians
- Current vitamin D recommendations
- All breastfed infants:	13 (31.7%)
- “high risk” infants:		14 (34.2%)
- Discuss, parent decide:	6   (14.7%)
- Don’t discuss:		8   (19.5%)

## Interim, preliminary results: Parent survey

- 1493 surveys entered
- 1419 on age-eligible children
- Mean age of children 12.0 (4.6) mo
- 35.8% non-white and/or Latino

## Interim, preliminary results: Parent survey

- 82.1% of children breastfed first month
- 74.% of those breastfed continued 6+ mos
- 78.3% of those breastfed 6+ mos received little/no formula supplementation
- 670 eligible children (58.2% of those initially breastfed)
- 11.5% of eligible children routinely received vitamin D

## Interim, preliminary results: Parent survey

- Rate of supplementation in non-white and/or Latino eligible children higher than in white, non-Hispanic  (19.7% vs. 8.6%, OR 2.57, 95% CI   1.58, 4.17)
- Patients of pediatricians who universally recommend vitamin D more likely to receive vitamin D (33.9% vs. 17.1%, OR 2.13, 95% CI  1.14, 4.00)

## Interim, preliminary results: Parent survey

- Beliefs of parents of eligible children

## Interim, preliminary results: Parent survey

- In multivariate model, independent predictors of vitamin D use
- Disagreeing with statement that vitamins unnecessary because breastmilk has everything needed (OR 16.0, 95% CI 5.0, 51.2)
- Disagreeing with statement that giving vitamins inconvenient (OR 2.5, 95% CI 1.1, 5.8)
- Agreeing with statement that pediatrician recommended vitamins (OR 21.2, 95% CI 7.4, 60.3)

## Interim, preliminary results: AP levels

- Blood for AP obtained on 137 children
- 5 insufficient quantity
- 1 hemolyzed
- 134 eligible for analysis
- 17 AP values (13.0%) higher than lab “normals)
- 4  AP values (3.1%) >500

## Interim, preliminary results:Radiographs

- Radiographs obtained on 8 of 17 children with high AP levels (pending in 2)
- No definitive evidence of rickets on any radiograph
- For children with AP > 500, radiographs obtained on 3
- All normal
- Values returned to normal in 4th patient

## Challenges

- Intersection of research assistant visit to practice, eligible child, blood draw scheduled for clinical purposes less common than anticipated
- Practitioners have to complete IRB training to consent parents
- Research assistant conducts surveillance of practices to screen for potentially eligible patients

## Challenges

- Choices for “main” IRB:
- Children’s Hospital and Regional Medical Center
- University of Washington
- Virtually all of PSPRN practitioners on staff at Children’s
- One PSPRN practice owned by Children’s
- One PSPRN practice owned by private hospital corporation, has own IRB

## Challenges

- Recruiting patients with high AP for radiograph
- Rate higher than anticipated
- Issues when discussing radiograph with parents
- Avoiding unnecessary parental anxiety
- Avoid undermining child’s pediatrician
- Encourage participation

## IRB roulette

- UW recognizes Children’s IRB approval, but not vice-versa
- Need Children’s IRB approval for owned practice
- Children’s logical main IRB Choice
- Private hospital IRB recognizes UW approval, but not Children’s

## IRB roulette

- Strategy:  get Children’s IRB approval, approved study defines project
- UW then “approves” project
- Petition for “cooperative agreement” for private hospital IRB because of UW approval
- Children’s IRB approval 5/06, first application to private hospital IRB 6/06, revised 10/06, approved 5/07
- Required separate IRB training for PI, research assistant
- Credentialing of research assistant

## Interim, preliminary results:Physician survey

- statement	 		“universal”  others    P
- Guidelines		     4.8	      4.4	.13
- Not evidence-based	     3.1	      2.4    .05
- Lead to formula use	     4.3           1.6    .07
- Patients might get	     3.5           2.9    .19
- rickets