Background: Iron deficiency is common among female injection drug users, but it is unclear whether iron supplementation can reduce anemia and improve iron status without increasing plasma hepatitis C virus (HCV) or HIV RNA levels. Methods: We conducted a phase 3, double-blind, randomized, controlled clinical trial of daily micronutrients with 18 mg of iron (iron group) versus micronutrients without iron (control group) for 12 months among hepatitis C-positive female injection drug users in Baltimore, Maryland. The main outcome measures were hemoglobin, markers of iron status, plasma HCV RNA, plasma HIV RNA, and liver enzymes at 6 and 12 months of follow-up. Results: Four hundred fifty-eight women (320 HIV-negative and 138 HIV-positive) enrolled in the trial. There were no significant differences in the proportion of women with anemia, ferritin <30 ng/mL, loglo plasma HCV RNA, or log(10) plasma HIV RNA between treatment groups at enrollment. The proportion with anemia in the iron and control groups, respectively, was 20.7% versus 31.3% (P = 0.026) at 6 months and 26.2% versus 30.4% (P = 0.5) at 12 months; with ferritin <30 ng/mL, the proportion was 29.2% versus55.5%(P < 0.0001) at 6 months and 26.2% versus 46.9% (P= 0.0018) at 12 months. In the iron and control groups, respectively, mean loglo plasma HCV RNA (IU/mL) was 5.2 versus 5.2 (P = 0.86) at 6 months and 5.4 versus 5.3 (P = 0.6) at 12 months. Among HIV-positive subjects, mean log,0 plasma RNA (copies/mL) in the iron and placebo groups, respectively, was 3.8 versus 3.7 (P = 0.75) at 6 months and 3.7 versus 4.1 (P = 0.19) at 12 months. There were no significant differences in liver enzyme levels between the treatment groups at enrollment, 6 months, and 12 months. Conclusions: A daily micronutrient supplement with iron can reduce anemia and improve iron status in female injection drug users without increasing plasma HCV or HIV RNA levels or altering liver enzymes.
