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ZINC AND BIOCONDUCTUAL DEVELOPMENT IN EARLY CHILDHOOD

ZINC AND BIOCONDUCTUAL DEVELOPMENT IN EARLY CHILDHOOD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-083-05
Enrollment
300
Registered
2006-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

GROUP 1 Type of group
This group will be treated with 2 ml (1 teaspoon) of a syrup containing: Zinc Sulphate 10 mg / day, Ferrous Sulfate 10 mg / day and Copper Sulfate 0.6 mg / day, QD PO for 12 months. Group name:Group 2 Type of group
This group will be treated with 2 ml (1 teaspoon) of a syrup containing: Ferrous Sulfate 10 mg / day and Copper Sulfate 0.6 mg / day, QD PO for 12 months.

Sponsors

UNIVERSIDAD DE JOHNS HOPKINS E.E.U.U,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Birth weight greater than 2500 grams and having a gestational age greater than 37 weeks. 2) Have a good state of health. 3) Plan to live in the study area for the next 12 months.

Exclusion criteria

Exclusion criteria: 1) Presence of congenital malformations. 2) Presence of vision problems.

Design outcomes

Primary

MeasureTime frame
Outcome name:Clinical evaluation of a) Visual attention (visual habitation with heart rate monitoring). b) Executive processes. c) Test of games. Measure:Dimensions of cognitive development. Timepoints:a) Visual attention: 6, 9, and 12 months of age. b) Executive processes: 9, and 12 months of age. c) Test of games: 12 and 18 months of age.

Secondary

MeasureTime frame
Outcome name:Bayley Child Development Scales (BSID). Observations and maternal reports. Measure:Motor and behavioral sensory development. Timepoints:6,12, and 18 months of age. ; Outcome name:Zinc: Levels in plasma and urine. Iron: Hemoglobin, hematocrit, plasma ferritin. Copper: plasma levels, ceruloplasmin, neutropenia. Measure:Nutritional status of: Iron, Zinc and Copper. Timepoints:6,12, and 18 months of age. ; Outcome name:Subclinical infections: C-reactive protein. Growth: Length, weight, cephalic circumference, middle arm circumference, thickness of subcutaneous folds. Measure:Morbidity Growth of the subjects. Timepoints:CRP: 6.12, and 18 months of age. Growth evaluation: 6, 9, 12, 15 and 18 months of age.

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)