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Oral iron supplementation with a micronutrient powder (Sprinkles®) provided to children with moderate‐to‐severe malnutrition does not increase infectious morbidity risk: a randomized, double‐blind, placebo‐controlled, non‐inferiority safety trial
Author(s) -
Lemaire Mathieu,
Abedin Fahmida,
Shen Hua,
Islam Qazi Shafayetul,
Aziz Marufa,
Haseen Farhana,
Parveen Monira,
Chowdhury Jalal,
Hyder Ziauddin,
Cook Richard J,
Zlotkin Stanley H
Publication year - 2010
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.24.1_supplement.94.7
Subject(s) - medicine , micronutrient , placebo , relative risk , confidence interval , diarrhea , randomized controlled trial , anemia , pediatrics , alternative medicine , pathology
Background A link between iron supplementation (IS) and infectious morbidity (IM) has been suggested, particularly in children with moderate to severe malnutrition (MSM). Two meta‐analyses concluded that oral IS is safe, but children with MSM were excluded. Methods This is a randomized, double‐blind, placebo‐controlled, non‐inferiority (NI) safety trial using a 2‐mo course of iron‐containing micronutrient or placebo powder (I‐MNP and PP) in 268 Bangladeshi children aged 12–24 mo with MSM (weight‐forage Z‐score ≤ −2). NI margin was set at 20%. Primary outcome was a composite of diarrhea, dysentery and lower respiratory tract infection episodes (D/D/L) recorded through home visits every 2 days (first 2 mo) and then twice a week (next 4 mo post‐intervention). To capture seasonal effects, one group was studied in the summer and another in the winter. Univariate Anderson‐Gill model was used to analyze recurrent events. Results Baseline characteristics were similar. Combined relative risk (RR) of D/D/L for I‐MNP vs. PP was 0.81 (95% confidence interval [CI] 0.62–1.04; p=0.09). Winter group RR was lower at 0.6 (CI 0.42–0.85; p=0.004) than summer group RR, at 0.98 (CI 0.69–1.38, p=0.9), p=0.052. There were no reported deaths. Conclusion Risk of IM was not higher for I‐MNP vs. PP. Since IM rates were lower than anticipated, NI is not confirmed. I‐MNP was more protective for the winter group, suggesting a seasonal effect. Grant Funding Source : Thrasher Research Fund