CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Docosahexaenoic acid (DHA) +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01051154
NCT01051154Phase 2Completed
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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

Coordinación de Investigación en Salud, Mexico·interventional·Posted Jan 18, 2010·Updated Aug 22, 2016

In Brief

A Phase 2 clinical trial evaluating Docosahexaenoic acid (DHA) and Placebo for Acute Lymphoblastic Leukemia and Malnutrition. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia, Malnutrition
CountriesMexico
CollaboratorsNational Council of Science and Technology, Mexico, Instituto Mexicano del Seguro Social

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 18, 2010
Enrollment StartSep 1, 2010
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 16.5 years ago

Interventions

Docosahexaenoic acid (DHA)dietary

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.

Placebodietary

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.