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

Richard D. Semba, Erin P. Ricketts, Shruti Mehta, Dale Netski, David Thomas, Gregory Kirk, Albert W. Wu, David Vlahov

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)298-303
Number of pages6
JournalJournal of Acquired Immune Deficiency Syndromes
Volume45
Issue number3
DOIs
StatePublished - Jul 1 2007

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Keywords

  • Anemia
  • HIV
  • Hemoglobin
  • Hepatitis C
  • Iron
  • Micronutrients
  • Women

ASJC Scopus subject areas

  • Infectious Diseases
  • Pharmacology (medical)

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