Iron supplementation in HIV-infected Malawian children with anemia: a double-blind, randomized, controlled trial.
Study Goal
The researchers aimed to determine whether iron supplementation is safe and beneficial for HIV-infected children with moderate anemia in malaria-endemic regions, focusing on hemoglobin levels, HIV progression, and morbidity.
Results Summary
Iron supplementation improved hemoglobin levels, reduced persistent anemia, and enhanced CD4 percentage response but increased malaria incidence, particularly in the first 3 months.
Population
HIV-infected Malawian children aged 6-59 months with moderate anemia (hemoglobin 7.0-9.9 g/dL).
Effective Dosage
3 mg/kg/day of elemental iron with multivitamins (vitamins A, C, and D).
Duration
3 months of intervention, 6 months of follow-up.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
iron supplementation and multivitamins (vitamins A, C, and D) | increase | hemoglobin concentrations | HIV-infected Malawian children aged 6-59 months with moderate anemia | adjusted mean difference (aMD), 0.60; 95% confidence interval (CI), .06-1.13; P = .03 | was associated with greater increases in | #1 |
iron supplementation and multivitamins (vitamins A, C, and D) | decrease | anemia persisting for up to 6 months follow-up | HIV-infected Malawian children aged 6-59 months with moderate anemia | adjusted prevalence ratio, 0.59; 95% CI, .38-.92; P = .02 | reduced the risk of | #2 |
iron supplementation and multivitamins (vitamins A, C, and D) | increase | CD4 percentage response at 3 months | HIV-infected Malawian children aged 6-59 months with moderate anemia | aMD, 6.00; 95% CI, 1.84-10.16; P = .005 | had a better | #3 |
iron supplementation and multivitamins (vitamins A, C, and D) | increase | malaria at 6 months | HIV-infected Malawian children aged 6-59 months with moderate anemia | incidence rate, 120.2 vs 71.7; adjusted incidence rate ratio (aIRR), 1.81 [95% CI, 1.04-3.16]; P = .04 | had an increased incidence of | #4 |
iron supplementation and multivitamins (vitamins A, C, and D) | increase | malaria during the first 3 months | HIV-infected Malawian children aged 6-59 months with moderate anemia | incidence rate, 78.1 vs 36.0; aIRR, 2.68 [95% CI, 1.08-6.63]; P = .03 | had an increased incidence of | #5 |
BACKGROUND: It is unknown whether iron supplementation in human immunodeficiency virus (HIV)-infected children living in regions with high infection pressure is safe or beneficial. A 2-arm, double-blind, randomized, controlled trial was conducted to examine the effects of iron supplementation on hemoglobin, HIV disease progression, and morbidity. METHODS: HIV-infected Malawian children aged 6-59 months with moderate anemia (hemoglobin level, 7.0-9.9 g/dL) were randomly assigned to receive 3 mg/kg/day of elemental iron and multivitamins (vitamins A, C, and D) or multivitamins alone for 3 months. Participants were followed for 6 months. RESULTS: A total of 209 children were randomly assigned to treatment, and 196 (93.8%) completed 6 months of follow-up. Iron supplementation was associated with greater increases in hemoglobin concentrations (adjusted mean difference [aMD], 0.60; 95% confidence interval [CI], .06-1.13; P = .03) and reduced the risk of anemia persisting for up to 6 months follow-up (adjusted prevalence ratio, 0.59; 95% CI, .38-.92; P = .02). Children who received iron had a better CD4 percentage response at 3 months (aMD, 6.00; 95% CI, 1.84-10.16; P = .005) but an increased incidence of malaria at 6 months (incidence rate, 120.2 vs 71.7; adjusted incidence rate ratio [aIRR], 1.81 [95% CI, 1.04-3.16]; P = .04), especially during the first 3 months (incidence rate, 78.1 vs 36.0; aIRR, 2.68 [95% CI, 1.08-6.63]; P = .03). CONCLUSIONS: Iron supplementation in anemic HIV-infected children has beneficial effects on hemoglobin, anemia, and immunity but increases the risk of malaria. Thus, iron supplementation in HIV-infected children living in malaria-endemic areas should only be provided in combination with adequate protection from malaria. CLINICAL TRIALS REGISTRATION: ISRCTN-62947977.