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

July 10, 2023 updated by: María de Lourdes Barbosa Cortés, Coordinación de Investigación en Salud, Mexico

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maria de Lourdes Barbosa Cortés, PhD
  • Phone Number: 5514803521
  • Email: lulubc@gmail.com

Study Contact Backup

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: at the time of the recruitment, 6 weeks of supplementation and after 6 weeks without supplementation
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)
Time Frame: at the time of the recruitment, 6 weeks of supplementation and after 6 weeks without supplementation
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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