Clinical trial NCT05950204: Effect of Supplementation With ω-3 Fatty Acids, Vitamin D and Calcium in Patients With Acute Lymphoblastic Leukemia.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Mexicano del Seguro Social
First posted: 2023-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vitamin D status and changes in the concentrations of biomarkers of bone resorption
timeFrame: at the time of the recruitment, 6 weeks of supplementation and after 6 weeks without supplementation
Secondary outcomes:
measure: Concentrations of inflammatory markers (IL-6 and TFN)
timeFrame: at the time of the recruitment, 6 weeks of supplementation and after 6 weeks without supplementation
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Unit of research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: María de Lourdes Barbosa Cortés, PhD
role: PRINCIPAL_INVESTIGATOR
References: