Weekly Zinc Chelate Supplementation on Children's Growth

NCT01911260 | Completed Phase 2 Results

• 1 other identifier: APoblacionZinc
• Study Type: interventional
• Target: 199
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to measure the effect of weekly zinc supplementation on schoolchildren with growth deficit or normal stature.

Conditions

Short Stature

Keywords

Zinc; Growth; Child; Dietary Supplements; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

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

  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).

  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.

Study Arms (4)

Growth Deficit+zinc amino acid chelate

ACTIVE COMPARATOR

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). 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.

Dietary Supplement: Zinc amino acid chelate

Growth Deficit receiving placebo

PLACEBO COMPARATOR

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). 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.

Other: Placebo

Normal Height receiving placebo

PLACEBO COMPARATOR

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. 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.

Other: Placebo

Normal Height+zinc amino acid chelate

ACTIVE COMPARATOR

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. 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.

Dietary Supplement: Zinc amino acid chelate

Interventions

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.

Growth Deficit+zinc amino acid chelate; Normal Height+zinc amino acid chelate

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.

Growth Deficit receiving placebo; Normal Height receiving placebo

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Related Publications (1)

• Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.

  PMID: 36994923 DERIVED

MeSH Terms

Conditions

Dwarfism

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Limitations and Caveats

The sample loss is a factor that hinders the adoption of results as definitive. Even if they remained similar according to biodemographic variables, we cannot guarantee the maintenance of group equality defined in randomization.

Results Point of Contact

• Title: Ana Paula Poblacion
• Organization: Federal University of Sao Paulo

anapoblacion@yahoo.com.br

+55 11 55391783

Study Officials

• José Augusto AC Taddei, MD, Dr PH

  Federal University of São Paulo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Science

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 30, 2013
• Study Start: September 1, 2000
• Primary Completion: December 1, 2000
• Study Completion: March 1, 2001
• Last Updated: December 24, 2013
• Results First Posted: December 24, 2013

Record last verified: 2013-11