NCT01051154

Brief Summary

The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration during the first three months of treatment reduces the deterioration of nutritional status, treatment toxicity and early mortality in children with acute lymphoblastic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_2

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

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

5.9 years

First QC Date

January 15, 2010

Last Update Submit

August 19, 2016

Conditions

Acute Lymphoblastic LeukemiaMalnutrition

Keywords

Docosahexaenoic acidNutritional statusAcute lymphoblastic leukemiaLong chain polyunsaturated fatty acidsn-3 fatty acidsRemission-induction phase

Outcome Measures

Primary Outcomes (1)

  • Nutritional status will be determined by the register of anthropometrical measurements, body composition by DEXA, and biochemical markers.

    At the time of diagnosis and the first three months of treatment

Secondary Outcomes (2)

  • Treatment toxicity measured by complications and haematological and biochemical outcomes,will be evaluated according to criteria established by the World Health Organization.

    The first three months of treatment

  • Early mortality will be considered as the difference between the total number of individuals alive at the end of follow-up (3 months) unless the initial number of patients included in the study for each group

    The first three months of treatment

Study Arms (2)

Docosahexaenoic acid (DHA)

ACTIVE COMPARATOR

This group will be receive the DHA supplement

Dietary Supplement: Docosahexaenoic acid (DHA)

Placebo

PLACEBO COMPARATOR

This group will be receive placebo

Dietary Supplement: Placebo

Interventions

Docosahexaenoic acid (DHA)DIETARY_SUPPLEMENT

Children will be received either fish oil capsules (DHA group) or placebo capsules (placebo group) which is visually indistinguishable from DHA capsules (softgel). Each child will be receiving 100 mg/kg/day or placebo capsules without docosahexaenoic acid, during the first three months of treatment.

Also known as: omega 3 fatty acids, n-3 LC-PUFAs, long chain polyunsaturated fatty acids
Docosahexaenoic acid (DHA)
PlaceboDIETARY_SUPPLEMENT

Children will be received either fish oil capsules (DHA group) or placebo capsules (placebo group) which is visually indistinguishable from DHA capsules (softgel). Each child will be receiving 100 mg/kg/day or placebo capsules without docosahexaenoic acid, during the first three months of treatment.

Placebo

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with acute lymphoblastic leukemia diagnosis
  • Authorization from both parents or legal guardian for recruiting of the child into the study with consent signed form after the purpose and procedures have been explained
  • Must be able to swallow capsules of DHA or placebo
  • Malnutrition

You may not qualify if:

  • Patients had received radiotherapy or chemotherapy
  • Parents who decide to decline of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social

Mexico City, Mexico City, 06720, Mexico

Location

Related Publications (3)

  • Larsson SC, Kumlin M, Ingelman-Sundberg M, Wolk A. Dietary long-chain n-3 fatty acids for the prevention of cancer: a review of potential mechanisms. Am J Clin Nutr. 2004 Jun;79(6):935-45. doi: 10.1093/ajcn/79.6.935.

    PMID: 15159222BACKGROUND

  • Barbosa-Cortes L, Martinez-Vieyra X, Mejia-Arangure JM, Lopez-Alarcon M, Martin-Trejo J, Delgadillo-Portillo S, Guzman-Castro B, Delgadillo-Portillo J, Atilano-Miguel S, Rodriguez-Cruz M, Maldonado-Hernandez J, Anoveros-Barrera A, Solis-Labastida KA, Espinoza-Hernandez L, Nunez-Villegas NN, Jimenez-Hernandez E, Bautista-Martinez BA, Juarez-Moya A, Hernandez-Pinon Z, Perez-Casillas RX. Pilot study on the effect of supplementation with long-chain omega-3 polyunsaturated fatty acids on body composition in children with acute lymphoblastic leukemia: randomized clinical trial. Clin Nutr. 2023 Sep;42(9):1759-1769. doi: 10.1016/j.clnu.2023.06.022. Epub 2023 Jul 13.

    PMID: 37549598DERIVED

  • Barbosa-Cortes L, Atilano-Miguel S, Martin-Trejo JA, Jimenez-Aguayo E, Martinez-Becerril FI, Lopez-Alarcon M, Mejia Arangure JM, Maldonado-Hernandez J, Delgadillo-Portillo S, Guzman-Castro B, Delgadillo-Portillo J, Anoveros-Barrera A, Solis-Labastida KA, Bautista-Martinez BA, Juarez-Moya A, Hernandez-Pinon Z, Espinoza Hernandez LE, Nunez-Villegas NN, Jimenez-Hernandez E, Perez-Casillas RX. Effect of long-chain omega-3 polyunsaturated fatty acids on cardiometabolic factors in children with acute lymphoblastic leukemia undergoing treatment: a secondary analysis of a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Apr 14;14:1120364. doi: 10.3389/fendo.2023.1120364. eCollection 2023.

    PMID: 37124732DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaMalnutrition

Interventions

Docosahexaenoic AcidsFatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Maria de Lourdes Barbosa-Cortes, MSc

    Instituto Mexicano del Seguro Social

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Researcher

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 22, 2016

Record last verified: 2016-08

Locations

ME(1)