title: Effect of micronutrients and iron supplementation on hemoglobin, iron status, and plasma hepatitis C and HIV RNA levels in female injection drug users: a controlled clinical trial.
abstract: 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, log10 plasma HCV RNA, or log10 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% versus 55.5% (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 log10 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 log10 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.
authors.affiliation: Department of Ophthalmology, Johns Hopkins Medical Institutions, Baltimore, MD 21205, USA. rdsemba@jhmi.edu
authors.forename: Richard D
authors.initials: RD
authors.lastname: Semba
authors.forename: Erin P
authors.initials: EP
authors.lastname: Ricketts
authors.forename: Shruti
authors.initials: S
authors.lastname: Mehta
authors.forename: Dale
authors.initials: D
authors.lastname: Netski
authors.forename: David
authors.initials: D
authors.lastname: Thomas
authors.forename: Gregory
authors.initials: G
authors.lastname: Kirk
authors.forename: Albert W
authors.initials: AW
authors.lastname: Wu
authors.forename: David
authors.initials: D
authors.lastname: Vlahov
mesh_terms: D000328:Adult; D000740:Anemia; D018798:Anemia, Iron-Deficiency / Q000097:blood* / Q000150:complications / Q000628:therapy*; D019587:Dietary Supplements; D005260:Female; D005293:Ferritins / Q000097:blood*; D006678:HIV / Q000235:genetics* / Q000302:isolation & purification; D015658:HIV Infections / Q000097:blood* / Q000150:complications; D006454:Hemoglobins / Q000032:analysis*; D016174:Hepacivirus / Q000235:genetics* / Q000302:isolation & purification; D006526:Hepatitis C / Q000097:blood* / Q000150:complications; D006801:Humans; D007501:Iron / Q000008:administration & dosage / Q000627:therapeutic use*; D008396:Maryland; D018977:Micronutrients / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood*; D015819:Substance Abuse, Intravenous / Q000150:complications; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D006454:Hemoglobins; D018977:Micronutrients; D012367:RNA, Viral; D005293:Ferritins; D007501:Iron