Iron supplementation of low-income infants: a randomized clinical trial of adherence with ferrous fumarate sprinkles versus ferrous sulfate drops

J Pediatr. 2009 May;154(5):738-43. doi: 10.1016/j.jpeds.2008.11.003. Epub 2008 Dec 25.


Objective: To determine whether low-income infants' adherence to nutritional supplementation with ferrous fumarate sprinkles was better than that with ferrous sulfate drops.

Study design: The study was a randomized clinical trial of healthy 6-month-old infants. Each infant received either a daily packet of sprinkles or a dropperful of liquid. Follow-up included alternating telephone and home visits biweekly for 3 months. Adherence was defined as high if the infant's caregiver reported supplement use on 5 to 7 days during the week before assessment. Side effects and caregiver attitude about supplements were secondary outcomes. Analyses were conducted using generalized estimating equations and chi(2) and Wilcoxon rank-sum tests.

Results: A total of 150 of 225 eligible infants were enrolled. Adherence to supplementation was generally poor. High adherence ranged from 32% to 63% at any assessment in the subjects receiving drops, compared with 30% to 46% in those receiving sprinkles. The drops group was more likely to have at least four assessments with high adherence (22% vs 9.5%; P = .03). Caregivers of the drops infants were more likely to report greater than usual fussiness (P < .01); however, fussiness had no consistent impact on adherence.

Conclusions: The use of ferrous fumarate sprinkles rather than traditional ferrous sulfate drops did not improve adherence with daily iron supplementation in low-income infants.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Anemia, Iron-Deficiency / prevention & control*
  • Attitude to Health
  • Caregivers
  • Dietary Supplements
  • Dosage Forms
  • Feasibility Studies
  • Female
  • Ferrous Compounds / administration & dosage*
  • Humans
  • Income
  • Infant
  • Male
  • Medication Adherence*
  • Patient Acceptance of Health Care
  • Pilot Projects
  • Trace Elements / administration & dosage*
  • United States


  • Dosage Forms
  • Ferrous Compounds
  • Trace Elements
  • ferrous sulfate
  • ferrous fumarate