Acute Lymphoblastic Leukemia Clinical Trial
— DHA-ALLOfficial title:
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
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 15 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Mexico | Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social | Mexico | Distrito Federal |
Lead Sponsor | Collaborator |
---|---|
Coordinación de Investigación en Salud, Mexico | Instituto Mexicano del Seguro Social, National Council of Science and Technology, Mexico |
Mexico,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No |
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