NCT05493449

Brief Summary

Malnutrition is very common in Pakistan, especially in children of under developed areas due to lack of resources and access to nutritious food. It can disturb the normal physical and mental development as well as functioning in children which can put economic burden on country level. Therefore, school meal programs can play an important role in providing school children with healthy and nutritious food which can improve their nutritional status as well as overall health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,799

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

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

December 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2022

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

June 20, 2022

Last Update Submit

March 3, 2023

Conditions

Outcome Measures

Primary Outcomes (11)

  • Weight

    Weight of the study participants was measured by using weighing balance.

    change from baseline to 3 months

  • Height

    Height of the study participants was measured by using stadiometer.

    change from baseline to 3 months

  • Total Body Water (TBW)

    TBW of the study participants was measured by using body composition analyzer Inbody J-270.

    change from baseline to 3 months

  • Body Protein

    Body protein of the study participants was measured by using body composition analyzer Inbody J-270.

    change from baseline to 3 months

  • Minerals

    Body minerals of the study participants was measured by using body composition analyzer Inbody J-270.

    change from baseline to 3 months

  • Body Fat Mass (BFM)

    Body fat mass of the study participants was measured by using body composition analyzer Inbody J-270.

    change from baseline to 3 months

  • Skeletal Muscle Mass (SMM)

    SMM of the study participants was measured by using body composition analyzer Inbody J-270.

    change from baseline to 3 months

  • Percentage Body Fat (PBF)

    PBF of the study participants was measured by using body composition analyzer Inbody J-270.

    change from baseline to 3 months

  • Inbody Score

    Inbody Score of the study participants was measured by using body composition analyzer Inbody J-270.

    change from baseline to 3 months

  • Visceral Fat Level (VFL)

    VFL of the study participants was measured by using body composition analyzer Inbody J-270.

    change from baseline to 3 months

  • Waist to Hip ratio (WHR)

    WHR of the study participants was measured by using body composition analyzer Inbody J-270.

    change from baseline to 3 months

Secondary Outcomes (2)

  • Attendance percentage

    change from baseline to 3 months

  • Nutritional deficiency Assessment

    change from baseline to 3 months

Study Arms (3)

Control Group

NO INTERVENTION

In this group, no milk (intervention) was provided

UHT Milk

EXPERIMENTAL

In this group, UHT Milk intervention was provided

Combination Product: UHT Milk

Flavored Milk

EXPERIMENTAL

In this group, flavored milk was provided to participants

Combination Product: Flavored Milk

Interventions

UHT MilkCOMBINATION_PRODUCT

In this group of participants, UHT milk, 180 mL was provided and results were compared with control and flavored milk group

UHT Milk
Flavored MilkCOMBINATION_PRODUCT

In this group of participants, flavored milk, 180 mL was provided and results were compared with control and UHT group

Flavored Milk

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants aged 4-16 years of age enrolled under University of Education, Lahore who are having no symptoms of Lactose Intolerance

You may not qualify if:

  • Participants having symptoms of Lactose Intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Veterinary and Animal Sciences, Lahore

Lahore, 54000, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking is involved as participants, investigator and assessor know intervention types
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: There were three groups in study. Group A is the one which received UHT Milk, Group B received Flavored Milk and Group C was a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 20, 2022

First Posted

August 9, 2022

Study Start

December 1, 2021

Primary Completion

November 15, 2022

Study Completion

December 16, 2022

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations