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

Vitamin d Deficiency Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950204
• Other study ID #: 2019-785-021
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Maria de Lourdes Barbosa Cortés, PhD
• Phone: 5514803521
• Email: lulubc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Vitamin d Deficiency

Intervention

Dietary Supplement:
• ?-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate)
Intervention with 100 mg/kg/d of LCPUFA-?3 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.

Locations

Country	Name	City	State
Mexico	Unit of research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D status and changes in the concentrations of biomarkers of bone resorption	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-?3 will be analyzed by gas chromatography.	at the time of the recruitment, 6 weeks of supplementation and after 6 weeks without supplementation
Secondary	Concentrations of inflammatory markers (IL-6 and TFN)	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-?3, 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