Treatment response to iron and folic acid alone is the same as with multivitamins and/or anthelminthics in severely anemic 6- to 24-month-old children

J Nutr. 2009 Aug;139(8):1568-74. doi: 10.3945/jn.108.103507. Epub 2009 Jun 17.

Abstract

We assessed the effectiveness of iron+folic acid for the treatment of severe anemia [hemoglobin (Hb) <70 g/L] and the efficacy of added multivitamins and/or anthelminthics among children aged 6-24 mo in periurban Karachi, Pakistan. The study design was a double blind, placebo-controlled, randomized trial of currently recommended daily iron (25 mg) and folic acid (100 microg) for 90 d with daily multivitamins [vitamin A (300 microg, as retinol palmitate), vitamin E (6 mg tocopherol equivalents), vitamin B-12 (0.9 microg), vitamin C (15 mg), riboflavin (0.5 mg)] and/or anthelminthics (100 mg mebendazole twice daily for 3 d) compared with placebos. Treatment response was defined as reaching a Hb concentration > or =100 g/L at the end of 90 d. The prevalence of severe anemia in the 9518 children screened was 5.7% and a total of 462 severely anemic children were enrolled in the study. Adherence to treatment was approximately 70% for iron+folic acid, approximately 80% for multivitamins, and almost 100% for mebendazole. Children receiving iron+folic acid alone had a response rate of 38.7% at 90 d. The additional treatment with mebendazole or multivitamins did not significantly improve cure rates or change the Hb concentration over and above iron+folic acid treatment alone. Adherence to iron+folic acid of higher than the median resulted in a better treatment response rate of 50%. High-dose daily iron+folic acid performed as well as iron+folic acid with anthelminthics and multivitamins in the treatment of severe anemia in this setting. Higher adherence may be important in enhancing treatment impact.

Trial registration: ClinicalTrials.gov NCT00116493.

Publication types

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

MeSH terms

  • Anemia / drug therapy*
  • Anemia / epidemiology
  • Anemia, Iron-Deficiency / drug therapy*
  • Antinematodal Agents / therapeutic use*
  • Child, Preschool
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Folic Acid / administration & dosage
  • Folic Acid / therapeutic use*
  • Hemoglobins / metabolism
  • Humans
  • Infant
  • Iron / administration & dosage
  • Iron / therapeutic use*
  • Male
  • Mebendazole / therapeutic use*
  • Pakistan / epidemiology
  • Patient Compliance
  • Prevalence
  • Treatment Outcome
  • Vitamins / therapeutic use*

Substances

  • Antinematodal Agents
  • Hemoglobins
  • Vitamins
  • Mebendazole
  • Folic Acid
  • Iron

Associated data

  • ClinicalTrials.gov/NCT00116493