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We used a prospective, open-label randomized trial to evaluate two treatment regimens in Tanzanian children two months to four years of age presenting to a hospital with a packed cell volume (PCV) < 25%. Treatment was either standard (14 days of ferrous sulfate and an antimalarial) or extended (three months of ferrous sulfate and three antimalarial treatments). The prevalence of anemia was measured two weeks after completion of treatment and six months after recruitment. Two weeks after completing treatment, the prevalence of PCV < 33% was 58% in the standard treatment arm and 44% in the extended treatment group (P = 0.04), and the mean PCV was significantly higher in the extended treatment arm (32.1%, SD = 4.5% versus 30.8%, SD = 4.9%; P = 0.031). However, there was no difference in the prevalence of PCV < 25% in the first survey, and the benefits of extended therapy were only apparent six months after recruitment in children compliant with the extended treatment (odds ratio of PCV < 25% = 0.16, P = 0.06). Compliance was satisfactory in only 39% (82 of 209) of the children in the first week of treatment. Extending the duration of therapy and improving compliance may have health benefits for anemic children in malaria-endemic settings.
Received May 28, 2003. Accepted for publication March 29, 2004.
Acknowledgments: We are grateful to the mothers and children recruited into the study for their co-operation. We also thank the nursing staff at St. Francis Designated District Hospital and the Ifakara Mother and Child Health Clinic for facilitating patient flow to the study team. The trial was supported by Dr. Fred Lwilla (Kilombero District Medical Officer) and Dr. Patience Kibatala (Medical Director, St. Francis Designated District Hospital). Field activities were supervised by Morsad Nywage, data management by Chris Msokame, laboratory procedures by John Wigayi, and clinical activities by Athmani Malende.
Financial support: This investigation received financial support from the United Nations Development Program/World Bank/World Health Organization Special Program for Research and Training in Tropical Diseases.
Authors’ addresses: David Schellenberg, Centre for International Health, Institut d’Investigacions Biomedicas August Pi i Sunyer, Hospital Clinic, Villarroel 170, Barcelona 08036, Spain and Ifakara Health Research and Development Centre, PO Box 53, Ifakara, Tanzania, Telephone: 44-1296-681-160, Fax: 44-1296-681-099, E-mail: dmschellenberg{at}aol.com. Elizeus Kahigwa and Hassan Mshinda, Ifakara Health Research and Development Centre, PO Box 53, Ifakara, Tanzania. Sergi Sanz, John Aponte, Pedro Alonso, and Clara Menendez, Centre for International Health, Institut d’Investigacions Biomedicas August Pi i Sunyer, Hospital Clinic, Villarroel 170, Barcelona 08036, Spain.
Reprint requests: Clara Menendez, Centre for International Health, Institut d’Investigacions Biomedicas August Pi i Sunyer, Hospital Clinic, Villarroel 170, Barcelona 08036, Spain.
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