The primary objective of this study is to determine the efficacy of the The Lucky Iron FishTM (LIFTM) to increase Hb concentration in Cambodian women of reproductive age.
In rural Preah Vihear, we screened 1049 women for eligibility. 327 women (18-49 y) with mild or moderate anemia (Hb 80-120 g/L) were randomized to: 1) a LIFTM group, 2) a daily 18 mg elemental iron group, or 3) a control group. A venous blood sample was taken at baseline, after 6 months, and final data collection is scheduled for May 2016. Blood was analyzed for Hb concentration, serum ferritin (Fer) and soluble transferrin receptor (sTfR) (CRP- and AGP-adjusted). Hb electrophoresis was used to detect structural Hb variants.
Anemia prevalence (Hb<120g/L) was 43% based on screening with the HemoCue Hb 301. At baseline, prevalence of iron deficiency anemia (IDA) differed by biomarker: 8% with Fer (<12µg/L), and 22% with sTfR (>8.3 mg/L). 280 women remained at midline for Hb electrophoresis, 69% (n=193) of which have a structural Hb variant. At 6 months there was no significant difference in Hb concentration (marginal mean; 95% CI) between the LIF group (119.5; 117.1, 121.9 g/L), iron supplement group (118.3; 115.9, 120.7 g/L), and control group (119.6; 117.2, 122.1 g/L) (p = 0.7).
Preliminary analysis indicates a low prevalence of IDA in Preah Vihear. There is no significant improvement in Hb concentration among women cooking with the LIFTM compared to women in the iron supplement and control groups. Full data will be analyzed by September 2016.