NCT05498129

Brief Summary

This trial investigated the impact of providing a regular meal with and without additional multiple micronutrients for children in Northwest Pakistan on their performance at school, in comparison to a local government school that served as a control i.e. no school meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

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

September 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

August 8, 2022

Last Update Submit

January 13, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Ravens Colour Matrices test for assessment of Cognitive function

    Raven's Coloured Progressive Matrices. Raven's Coloured Progressive Matrices (RCPM) (20)is a widely used nonverbal intelligence test for children between the ages of 5 and 11 years. The test comprises 36-items in the form of three sets of 12 items, that increase in difficulty

    Baseline

  • Ravens Colour Matrices test for assessment of Cognitive function

    Raven's Coloured Progressive Matrices. Raven's Coloured Progressive Matrices (RCPM) (20)is a widely used nonverbal intelligence test for children between the ages of 5 and 11 years. The test comprises 36-items in the form of three sets of 12 items, that increase in difficulty

    6-months

  • Ravens Colour Matrices test for assessment of Cognitive function

    Raven's Coloured Progressive Matrices. Raven's Coloured Progressive Matrices (RCPM) (20)is a widely used nonverbal intelligence test for children between the ages of 5 and 11 years. The test comprises 36-items in the form of three sets of 12 items, that increase in difficulty

    12-months

Secondary Outcomes (7)

  • Height

    Baseline

  • Mass

    Baseline

  • Mid upper arm circumference

    Baseline

  • Height for age

    Baseline

  • Weight for age

    Baseline

  • +2 more secondary outcomes

Study Arms (3)

No school meal

ACTIVE COMPARATOR
Other: No school meal

School meal

EXPERIMENTAL
Other: School meal

School meal plus micronutrient powder

EXPERIMENTAL
Other: School meal plus micronutrient powder

Interventions

School lunch was comprised of rice, ghee and beef

School meal

School lunch plus micronutrient powder

School meal plus micronutrient powder

No school meal

No school meal

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Prep or class 1
  • Male/ female

You may not qualify if:

  • Any contraindicating condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonathan Sinclair

Preston, Lancashire, PR4 0PE, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 11, 2022

Study Start

September 1, 2017

Primary Completion

July 15, 2018

Study Completion

December 1, 2018

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations