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
Bibliographic record
Abstract
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
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".