Phase 3
N=199
Weekly Zinc Chelate Supplementation on Children's Growth
Short Stature
Bottom Line
View on ClinicalTrials.gov: NCT01911260 ↗Enrolled (actual)
199
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Change in Height-for-Age Z-score (HAZ) From End of Supplementation to End of Follow-up Period. — 0.04; -0.08; 0.10; 0.02 Z-Score — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zinc amino acid chelate (Dietary_supplement); Placebo (Other)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Federal University of São Paulo
- Primary completion
- Dec 2000
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Height-for-Age Z-score (HAZ) From End of Supplementation to End of Follow-up Period. |
0.04; -0.08; 0.10; 0.02 | <0.05 sig |
Summary
The purpose of this study is to measure the effect of weekly zinc supplementation on schoolchildren with growth deficit or normal stature.
Eligibility Criteria
Inclusion Criteria
- Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD). For the Normal Stature group(NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.
Exclusion Criteria
- Children of GD group were evaluated by a Pediatrician specialized in growth disorders with the objective of excluding any organic or genetic condition correlated with growth deficit.
Data sourced from ClinicalTrials.gov (NCT01911260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.