Effect of Supplementation With ω-3 Fatty Acids, Vitamin D and Calcium in Patients With Acute Lymphoblastic Leukemia.
- Conditions
- Vitamin d DeficiencyAcute Lymphoblastic Leukemia
- Interventions
- Dietary Supplement: ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate)
- Registration Number
- NCT05950204
- Lead Sponsor
- Coordinación de Investigación en Salud, Mexico
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- Patients with acute or chronic renal failure
- Added pathology
- Fish Hypersensitivity
- Down´s Syndrome
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate) 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 Group A ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate) 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Unit of research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
🇲🇽Mexico City, Mexico