A Study to Investigate the Impact of Fortified Malt Based on Immunity Outcomes in School Children

NCT ID: NCT02542865

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 924 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2018-07-06

Brief Summary

This study will test the hypothesis that a fortified malt based food may improve immunity outcomes in 7-10 year old school age children.

Detailed Description

This will be a single centre, multiple sites, open label, two-arm, parallel-group, stratified by gender, matched pair cluster randomised, controlled study in children aged 7-10 years.

Conditions

Growth and Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Test Group

Fortified malt based food (27 grams) made up in 150 mL lukewarm water administered twice daily

Group Type: EXPERIMENTAL

Fortified malt based food

Intervention Type: DIETARY_SUPPLEMENT

Fortified malt based food

Control Group

No treatment was administered

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fortified malt based food

Fortified malt based food

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Demonstrates understanding of the study and willingness to participate as evidenced by the parent's and/or LAR's voluntary written informed consent as well as written assent by the child and has received a signed and dated copyof the informed consent form as well as the assent form.
• Boys and girls aged between 7-10 years
• Child and parent/LAR understand and are willing, able and likely to comply with all study procedures and restrictions.
• Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon physical examination and absence of any condition that could affect the child's safety or wellbeing or their ability to understand and follow study procedures and requirements.
• Participants with HAZ of ≥-3 to ≤-1.

Exclusion Criteria

• Children in Care (CiC): A child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a CiC does not include a child who is adopted or has an appointed legal guardian.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Indication that child is likely to move out of geographical range of the study within the period of study intervention and activities, thus hindering the child's compliance to study activities.
• Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit, participation in any nutritional study or didactic nutrition education in the last 6 months of the screening visit and previous participation in this study.
• Child with severe anaemia (Hemoglobin <8g/dL).
• Children with history of use of immunosuppressive therapy e.g. oral corticosteroids or chemotherapy in past six months prior to the screening visit.
• Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the test product or procedures, on the discretion of study physician.
• Recent history [2 months] of serious infections, injuries and/ or surgeries in the opinion of the investigator.
• Children consuming nutritional supplements and/or health food drinks on a regular basis (≥3 times a week) in last 3 months.
• Child belonging to an employee of the sponsor or the study site or members of their immediate family or sibling of a child already enrolled in the study.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Pune, , India

Countries

India

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

204477

Identifier Type: -

Identifier Source: org_study_id