NCT03049826

Brief Summary

Background: There are few studies about nutrition to children and adolescents with cancer, and in particular during stem cell transplantation (SCT). Studies from other countries suggest that malnutrition is common on admission; the situation decline during treatment and may persist for a long time. Aim: This project aims to improve the nutritional therapy to children being treated for cancer and children undergoing stem cell transplantation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

4.9 years

First QC Date

February 1, 2017

Last Update Submit

September 8, 2022

Conditions

Keywords

nutrient

Outcome Measures

Primary Outcomes (1)

  • Body composition meassured with Lunar Dxa

    After one year

Secondary Outcomes (4)

  • Blood vitamins and minerals

    After one year

  • Dietary intake

    After one year

  • Physical activity

    After one year

  • Health related Quality of life

    After one year

Study Arms (3)

Stem cell transplantation (SCT)

EXPERIMENTAL

Children undergoing stem cell transplantation (SCT)

Other: Nutritional status

Home parenteral nutrition (HPN)

NO INTERVENTION

Children receiving home parenteral nutrition

Healthy reference group

NO INTERVENTION

Healthy children

Interventions

Body composition and nutrient status

Stem cell transplantation (SCT)

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Oslo

Oslo, 0316, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Christine Henriksen, PhD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assossiate Professor

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 10, 2017

Study Start

February 1, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations