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

Sponsor

Coordinación de Investigación en Salud, Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT05950204

Collaborator

Instituto Mexicano del Seguro Social (Other)

Enrollment

Location

Arms

27.7

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia Vitamin d Deficiency	Dietary Supplement: ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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.

Actual Study Start Date :

Sep 10, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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: LCPUFA-ω3 Vitamin D Calcium
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: LCPUFA-ω3 Vitamin D Calcium

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:

LCPUFA-ω3

Vitamin D

Calcium

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)

Other Names:

LCPUFA-ω3

Vitamin D

Calcium

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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