Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia
1 other identifier
interventional
120
1 country
1
Brief Summary
This is a randomised, controlled, open-label intervention study. It is hypothesized that supplementation with a fibre enriched sip feed will improve the nutritional status, gut microbiota and quality of life (QOL) of children with acute lymphoblastic leukemia, and may enhance their immune response. This could give them a better chance to finish their induction chemotherapy successfully with fewer side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 15, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 10, 2015
February 1, 2015
2.7 years
May 15, 2012
February 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study Parameters
Primary * Change in body weight between Baseline and Day 42 \[kg, weight-for-age z score, weight-for-height z-score\] * Percentage of children with body weight loss between Baseline and Day 42 \[%\]
42 days
Secondary Outcomes (1)
Study Parameters
from day 1 to day 91 of the study
Study Arms (2)
NutriniDrink/Fortini group
ACTIVE COMPARATORthis group will receive 2 bottles of NutriniDrink/Fortini MF unflavoured daily (200 ml each) and standard dietary counselling for a period of 6 weeks.
control group
NO INTERVENTIONthis control group will only receive standard dietary counselling
Interventions
During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).
Eligibility Criteria
You may qualify if:
- Age should be above 2 years and children should be pre-pubertal.
- Hospitalized for the entire (6 week) intervention period.
- About to receive? induction chemotherapy.
- Able to tolerate oral feeding.
- Written informed consent from parents/guardian (and child, if applicable to local law).
You may not qualify if:
- ALL patients \< 2 years and those who show signs of puberty.
- ALL patients who cannot tolerate oral feeding and/or are on parenteral nutrition.
- ALL patients with a known history of cow's milk allergy/intolerance or galactosemia.
- ALL patients requiring a fibre-free diet.
- Investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements.
- Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's cancer Hospital Egypt-57357
Cairo, 11441, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alaa El-Hadad, PhD
Children's Cancer Hospita Egypt-57357
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2012
First Posted
May 17, 2012
Study Start
December 1, 2011
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
February 10, 2015
Record last verified: 2015-02