Weekly Zinc Chelate Supplementation on… | Clinical Trial

Key information

Conditions

Short Stature Bone Diseases Bone Diseases, Developmental Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Endocrine System Diseases Genetic Diseases, Inborn Musculoskeletal Diseases

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Zinc is an important micronutrient for humans. Trials with zinc have shown positive effects of supplementation on growth, but there is still a lack of results on schoolchildren population. This Randomized Double-Blind Controlled Trial was design to measure the effect of weekly zinc supplementation on schoolchildren with growth deficit and normal stature. Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ < -1,5 Z-score), and Normal Stature (HAZ between -1,0 and ±1,0 Z-score) and were randomly assigned to compose two exposed and two control groups to receive a supplement of 30mg of zinc amino acid chelate or placebo individually once a week, during 12 weeks. Children's heights were measured at the end of supplementation period and again after 12 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zinc amino acid chelate

Dietary Supplement

During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.

Placebo

Other

During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.

Primary outcomes

Change in Height-for-Age Z-score (HAZ) From End of Supplementation to End of Follow-up Period.

Time frame: Height-for-Age Z-score was measured at the End of Supplementation period and again at the End of Follow-up period, with a 12 weeks interval.

Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ < -1,5 Z-score), and Normal Height (HAZ between -1,0 and ±1,0 Z-score), and were randomly assigned to compose two exposed groups to receive a supplement of 30mg of zinc amino acid chelate, and two control groups to receive placebo individually once a week, during 12 weeks. Children's heights were measured at the End of Supplementation period and again after 12 weeks (Follow-up period). In combination with sex and age we transformed stature to Height-for-Age, expressed in Z-score, which was calculated as a number of standard deviations or Z-scores below or above the reference mean or median value, according to the formula below:

Z-score = (observed value - median value of the reference population) / standard deviation value of reference population.

We analyzed and discussed the change in HAZ (HAZ at the End of Follow-up period - HAZ at End of Supplementation).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Effect of Weekly Zinc Chelate Supplementation on Schoolchildren's Growth: a Randomized Double-blind Controlled Trial

Acronym: APZinc

Important dates

Study start: 2000
Primary completion: 2000
Study completion: 2001
First posted: Jul 30, 2013
Registry last updated: Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed