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

NCT02542865 | Completed Results

• 1 other identifier: 204477
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth and Development

Outcome Measures

Primary Outcomes (1)

• Total Number of Ill Days Due to Gastrointestinal (GI) and Respiratory Illness at Month 9

  Number of days a participant was ill due to GI and/or respiratory illness as diagnosed by physician, as per criteria defined, over the intervention duration. This equals total number of days (symptomatic or asymptomatic) in illnesses episodes whereas each episode is defined as an incidence of illness followed by at least 3 symptoms free days. GI illness was defined as an acute illness that includes any of following symptoms:3 or more loose/liquid/watery stools and/or vomiting in 24hours (h). Respiratory illness was defined as an acute illness that included more than or equal to \[\>=\] 1 of the following symptoms: runny nose, stuffy or blocked nose, cough fever or chills, sore throat or sneezing.

  At month 9

Secondary Outcomes (19)

• Frequency of GI and Respiratory Illnesses at Month 9

  At month 9

• Severity of GI Illnesses at Month 9

  At month 9

• Severity of Respiratory Illnesses at Month 9

  At month 9

• School Absenteeism Assessment Due to GI and Respiratory Illnesses at Month 9

  At month 9

• Change From Baseline in Body Mass Index (BMI) at Month 9

  At screening and month 9

Study Arms (2)

Test Group

EXPERIMENTAL

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

Dietary Supplement: Fortified malt based food

Control Group

NO INTERVENTION

No treatment was administered

Interventions

Fortified malt based food DIETARY_SUPPLEMENT

Fortified malt based food

Test Group

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Pune, 411001, India

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: July 24, 2017
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: December 5, 2019
• Results First Posted: December 5, 2019

Record last verified: 2019-11

Locations

IN (1)