NCT05177679

Brief Summary

The aim of this study is to test the casual relationship between carotenoid supplementation, cognitive function, and achievement over a school-year. The central hypothesis is that, relative to the waitlist placebo group, children receiving the carotenoid supplement will exhibit greater gains in cognitive function and achievement.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

November 2, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

June 23, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

November 2, 2021

Last Update Submit

April 26, 2023

Conditions

Cognitive ChangeAchievementMacular Pigmentation

Keywords

LuteinZeaxanthinCarotenoidsChildSpatial memoryHippocampusAcademic successCognition

Outcome Measures

Primary Outcomes (4)

  • Attentional Accuracy

    Changes in accuracy (%) between groups using a computerized flanker task.

    9 months (Baseline vs Follow-up)

  • Attentional Reaction Time

    Changes in reaction time (ms) between groups using a computerized flanker task.

    9 months (Baseline vs Follow-up)

  • Hippocampal-dependent Relational memory

    Spatial memory task accuracy

    9 months (Baseline vs Follow-up)

  • Composite Academic Achievement

    Kaufman Test of Academic and Educational Achievement II (KTEA III) composite or comprehensive academic achievement score. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.

    9 months (Baseline vs Follow-up)

Secondary Outcomes (7)

  • Macular Pigment Optical Density

    9 months (Baseline vs Follow-up)

  • Attentional Resource Allocation

    9 months (Baseline vs Follow-up)

  • Attentional Processing Speed

    9 months (Baseline vs Follow-up)

  • Math

    9 months (Baseline vs Follow-up)

  • Reading

    9 months (Baseline vs Follow-up)

  • +2 more secondary outcomes

Study Arms (2)

Active Supplement

EXPERIMENTAL

The active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months.

Dietary Supplement: Active supplement

Placebo Control

PLACEBO COMPARATOR

The placebo control group participants will be asked to consume a placebo supplement for 9 months.

Dietary Supplement: Placebo control

Interventions

Active supplementDIETARY_SUPPLEMENT

Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.

Active Supplement
Placebo controlDIETARY_SUPPLEMENT

Placebo control supplement

Placebo Control

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child assent and parent/guardian consent
  • years of age
  • No lutein supplementation within 6-months prior to enrollment (exception of multivitamins containing less than 1 mg lutein/day)
  • Absence of learning disability (parent-reported)
  • Tanner scale score ≤ 2
  • /20 or corrected vision

You may not qualify if:

  • Non-assent of child or non-consent of guardian
  • Above/below 8-10 years of age
  • Lutein supplementation within 6-months prior to enrollment (including multivitamins containing more than 1 mg lutein/day)
  • Identified learning disability (parent-reported)
  • Tanner scale score \> 2
  • Not 20/20 or uncorrected vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

Related Publications (1)

  • Cannavale CN, Keye SA, Rosok L, Martell S, Holthaus TA, Reeser G, Raine LB, Mullen SP, Cohen NJ, Hillman CH, Hammond BR, Renzi-Hammond L, Khan NA. Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. Contemp Clin Trials. 2022 Nov;122:106964. doi: 10.1016/j.cct.2022.106964. Epub 2022 Oct 15.

    PMID: 36252934DERIVED

Study Officials

  • Naiman Khan, PhD

    University of Illinois Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naiman Khan, PhD

CONTACT

217-300-2197nakhan2@illinois.edu

Ginger Reeser, MS

CONTACT

217-244-8442reeser2@illinois.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, placebo-controlled, double-blind trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2021

First Posted

January 4, 2022

Study Start

June 23, 2022

Primary Completion

May 31, 2025

Study Completion

April 30, 2026

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)