Clinical trial · Interventional
Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia
The Effect of Enteral Administration of Polyunsaturated Omega-3 Fatty Acids on Nutritional Status; the Treatment Toxicity and Early Mortality in Children With Acute Lymphoblastic Leukemia - a Controlled Study
NCT01051154CI-TRIAL-00023601DHA-ALLcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Malnutrition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docosahexaenoic acid (DHA) | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Docosahexaenoic acid (DHA)
- description
- This group will be receive the DHA supplement
- interventionNames
- Dietary Supplement: Docosahexaenoic acid (DHA)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- This group will be receive placebo
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- Nutritional status will be determined by the register of anthropometrical measurements, body composition by DEXA, and biochemical markers.
- timeFrame
- At the time of diagnosis and the first three months of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Patients had received radiotherapy or chemotherapy * Parents who decide to decline of the study
References
Publications (3)
- BACKGROUNDLarsson 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 15159222
- DERIVEDBarbosa-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 37549598
- DERIVEDBarbosa-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 37124732