NCT05950204

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Coordinación de Investigación en Salud, Mexico · Other Government
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Lymphoblastic Leukemia
• Vitamin d Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-10
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-07-18
• Last updated: 2023-07-18

Locations

1 site across 1 country: Mexico