Clinical Trial: Effect of Hookworm Elimination and Vitamin A Intervention on Iron Status of Preschool Children in Sichuan, China
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Chengdu Women's and Children's Central Hospital
Brief Summary: The present study is intended to supplement the preschool anemic children with vitamin A capsule and de-hookworm administration in poverty Sichuan province. We eventually expect our study can provide a cost-effective, safe and more beneficial public health strategy to manage the anemia status of preschool children in poverty area.
Detailed Summary:
Subjects and ethical approval This randomized, control and double-blinded cohort study was performed in Dayi, Pixian and Meishan country, Sichuan Province, western China, which are suburbs of Chengdu city with a low class of socioeconomic status, from March 2012 to September 2014 and approximately about 216 anemic preschool children aged 3-6 years were randomly recruited from nine kindergartens of the three countries for the study during intervention period. The eligibility criteria for participation were as follows: 1) apparent health; 2) Hb concentration <110 g/l but not <80 g/l; 3) C-reaction protein (CRP) <10 mg/L; 4) parental or guardian approval of participation in all aspects of the study; and 5) parental/guardian agreement to avoid the additional use of vitamin and mineral supplements and de-hookworm administration during the trial. Children with Hb<80 g/l and /or CRP >10 mg/l were sent to hospital with special treatment.
We conducted a census in each regional kindergarten to determine which households included an eligibility preschool children. Then field health workers conducted a family survey to determine which children was included. Eligible families were visited by a field worker who explained the protocol, answered questions, and obtained written informed consent from parents/guardians. The enrollment and research plan were reviewed and approved by the institutional ethics committee of the Chengdu Women's and Children's Central Hospital of Chongqing Medical University in Sichuan province, China. The present study complied with the code of ethics of the World Medical Association (Declaration of Helsinki).
The primary objective for the present study was to measure the change in serum Hb before and after intervention. A sample size of about 60 anemic preschool children per group was required to d
Sponsor: Chengdu Maternal and Children's Health Care Hospital
Current Primary Outcome: Hemoglobin concentration [ Time Frame: six month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Chengdu Maternal and Children's Health Care Hospital
Dates:
Date Received: August 28, 2015
Date Started: March 2012
Date Completion:
Last Updated: February 4, 2016
Last Verified: February 2016
