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

Effect of Combined Supplementation With Long-chain ω-3 Polyunsaturated Fatty Acids, Vitamin D, and Calcium as a Potential Adjuvant in the Preservation of Bone Mass and Bone Turnover Biomarkers in Patients With Acute Lymphoblastic Leukemia.

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Lymphoblastic Leukemia; Vitamin d Deficiency
• Intervention / Treatment: Dietary supplement: ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate)

Detailed Description

In pediatric hematological patients, the administration of high and prolonged doses of corticosteroids has a negative effect on bone metabolism, causing a significant reduction in bone mineral density (BMD). Maintaining adequate levels of vitamin D (VD) and calcium is crucial for bone health, and deficiencies in these nutrients increase the risk of osteoporosis. Children with acute lymphoblastic leukemia (ALL) have been found to have a high prevalence of VD deficiency. Bone turnover markers (BTMs) are substances produced by osteoblasts and osteoclasts that provide information about the dynamic remodeling of bone. Limited research has investigated the role of BTMs in pediatric ALL patients receiving VD supplementation.

Emerging evidence suggests that long-chain ω-3 polyunsaturated fatty acids (LCPUFA-ω3) play a significant role in bone health. Consumption of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) may inhibit bone resorption and promote bone formation in humans.

Currently, there are no randomized controlled clinical trials comparing the effects of combined supplementation with LCPUFA-ω3, VD, and calcium on BTMs in children with cancer.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria de Lourdes Barbosa Cortés, PhD; Phone Number: 5514803521; Email: lulubc@gmail.com
• Study Contact Backup: Name: Jorge3 Maldonado Hernandez; Phone Number: 5518433131; Email: jormh@yahoo.com.mx

Study Locations

• Mexico
  • Mexico City, Mexico, 06720
    • Recruiting
    • Unit of research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
    • Contact: Maria de Lourdes Barbosa Cortes 33, PhD; Phone Number: 5514803521; Email: lulubc@gmail.com
    • Contact: Jorge Maldonado Hernandez, PhD; Phone Number: 5518433131; Email: jormh@yahoo.com.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; 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); 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.; Other Names: Vitamin D; Calcium; LCPUFA-ω3
Active Comparator: Group B; 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); 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.; Other Names: Vitamin D; Calcium; LCPUFA-ω3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentrations of inflammatory markers (IL-6 and TFN)	changes in the concentrations of inflammatory markers (IL-6 and TFN) in a cohort of children with ALL undergoing treatment after 3 months of supplementation with LCPUFA-ω3, VD, and calcium compared to a group receiving only calcium and VD	at the time of the recruitment, 6 weeks of supplementation and after 6 weeks without supplementation

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Collaborators: Instituto Mexicano del Seguro Social
• Investigators: Principal Investigator: María de Lourdes Barbosa Cortés, PhD, Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin D; n-3 fatty acids; Acute Lymphoblastic Leukemia; Corticosteroids; Bone Mineral Density; Bone Turnover Biomarkers; Long-Chain polyunsaturated fatty acids
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Leukemia; Vitamin D Deficiency; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antacids; Vitamin D; Cholecalciferol; Calcium; Vitamins; Calcium, Dietary; Ergocalciferols; Calcium Carbonate
• Other Study ID Numbers: 2019-785-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No