Effect of Supplementation With ω-3 Fatty Acids, Vitamin D and Calcium in Patients With Acute Lymphoblastic Leukemia.

NCT05950204 | Unknown DMC

• 1 other identifier: 2019-785-021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of supplementation with Omega 3, Vitamin D and Calcium, in a cohort of children with ALL undergoing treatment and compare changes in the concentrations of biomarkers of bone resorption (TRAP5b, CTX, and RANKL), the RANKL/OPG ratio, and biomarkers of bone formation (BALP, OC, PINP, PICP and OPG) after 6 and 12 weeks of supplementation.

Conditions

Acute Lymphoblastic Leukemia; Vitamin d Deficiency

Keywords

Acute Lymphoblastic Leukemia; Bone Turnover Biomarkers; Corticosteroids; Bone Mineral Density; Long-Chain polyunsaturated fatty acids; n-3 fatty acids; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Vitamin D status and changes in the concentrations of biomarkers of bone resorption

  After 6 weeks of supplementation, VD (1-25 hydroxyvitamin D) levels will be evaluated by liquid chromatography coupled to high-resolution mass spectrometry (Waters Acquity UPLC H-Class). The biomarkers of BTMs will be analyzed by ELISA. Parathormone, phosphorus and calcium will be assessed by spectrophotometry, and 3 LCPUFA-ω3 will be analyzed by gas chromatography.

  at the time of the recruitment, 6 weeks of supplementation and after 6 weeks without supplementation

Secondary Outcomes (1)

• Concentrations of inflammatory markers (IL-6 and TFN)

  at the time of the recruitment, 6 weeks of supplementation and after 6 weeks without supplementation

Study Arms (2)

Group A

ACTIVE COMPARATOR

100 mg/kg/d of LCPUFA-ω3 with a ceiling dose of 3 g/d, + 1,000 mg of calcium/day and 4,000 IU (100 µg)/d of VD in those children \> 9 years and 20,000 UI/week = 2,857 UI/d in those \< 8 years for 6 weeks

Dietary Supplement: ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate)

Group B

ACTIVE COMPARATOR

1,000 mg of calcium/day and 4,000 IU (100 µg)/d of VD in those children \> 9 years and 20,000 UI/week = 2,857 UI/d in those \< 8 years for 6 weeks

Dietary Supplement: ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate)

Interventions

ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate) DIETARY_SUPPLEMENT

Intervention with 100 mg/kg/d of LCPUFA-ω3 with a ceiling dose of 3 g/d, + 1,000 mg of calcium/day and 4,000 IU (100 µg)/d of VD in those children \> 9 years and 20,000 UI/week = 2,857 UI/d in those \< 8 years for 6 weeks. The other group of patients will receive only the same dose of VD and calcium.

Also known as: LCPUFA-ω3, Vitamin D, Calcium

Group A; Group B

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with acute lymphoblastic leukemia in maintenance
• authorization from both parents or legal guardian for recruiting of the child into the study with consent have been explained
• Must be able to swallow capsules

You may not qualify if:

• Patients with acute or chronic renal failure
• Added pathology
• Fish Hypersensitivity
• Down´s Syndrome

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

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

Mexico City, 06720, Mexico

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Vitamin D Deficiency

Interventions

Vitamin D; Cholecalciferol; Calcium; Calcium Carbonate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Calcium Compounds; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• María de Lourdes Barbosa Cortés, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria de Lourdes Barbosa Cortés, PhD

CONTACT

5514803521; lulubc@gmail.com

Jorge3 Maldonado Hernandez

CONTACT

5518433131; jormh@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated researcher

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 18, 2023
• Study Start: September 10, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)