NCT00589264

Brief Summary

Zinc is necessary for growth and development, including the central nervous system, and zinc deficiency which is common in resource-poor settings, may adversely affect social, behavorial, cognitive and sensorimotor development. The project, located in Lima Peru, utilizes an experimental model in which children receive 10 mg supplemental zinc (or not) daily along with 10 mg iron and 1/2 mg copper from 6 months of age to 18 months of age. Beginning at 6 months of age, and at 9, 12, and 18 months, children are evaluated in multiples aspects of development. Children are also followed for their diet, growth, and health status. We hypothesize that children in this setting in which the diet is low in zinc who receive supplemental zinc will have better information processing skills, sensorimotor and behavioral development than their counterparts who do not receive supplemental zinc.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

3.8 years

First QC Date

December 24, 2007

Last Update Submit

September 8, 2014

Conditions

Child Development

Keywords

zincironchild developmentvisual attentionPeru

Outcome Measures

Primary Outcomes (1)

  • cognitive development(visual attention, executive processing, vigilance)

    6, 9, 12, and 18 months

Study Arms (2)

1

EXPERIMENTAL

iron + copper + zinc

Dietary Supplement: zinc

2

ACTIVE COMPARATOR

iron + copper only

Dietary Supplement: iron + copper

Interventions

zincDIETARY_SUPPLEMENT

10 mg elemental zinc + 10 mg elemental iron + 0.5 mg copper syrup taken daily for 1 year, from 6 to 18 months of age

1
iron + copperDIETARY_SUPPLEMENT

10 mg elemental iron + 0.5 mg copper in syrup given daily for one year from 6 months to 18 months of age

2

Eligibility Criteria

Age6 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Born at term of non-low birth weight
  • Free of major malformations, genetic abnormalities or health problems associated with developmental delays
  • Planning to remain in study area for one year
  • In good general health

You may not qualify if:

  • Low birth weight
  • Non-term delivery
  • Vision or hearing problems
  • Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Investigacion Nutricional

Lima, Peru

Location

Related Publications (2)

  • 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: 36994923DERIVED

  • Colombo J, Zavaleta N, Kannass KN, Lazarte F, Albornoz C, Kapa LL, Caulfield LE. Zinc supplementation sustained normative neurodevelopment in a randomized, controlled trial of Peruvian infants aged 6-18 months. J Nutr. 2014 Aug;144(8):1298-305. doi: 10.3945/jn.113.189365. Epub 2014 May 21.

    PMID: 24850625DERIVED

MeSH Terms

Interventions

ZincIronCopper

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Laura E Caulfield, PhD

    Johns Hopkins Bloomberg SPH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 24, 2007

First Posted

January 9, 2008

Study Start

July 1, 2004

Primary Completion

May 1, 2008

Study Completion

June 1, 2009

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

PE(1)