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Trial Title:
Effect of Supplementation With ω-3 Fatty Acids, Vitamin D and Calcium in Patients With Acute Lymphoblastic Leukemia.
NCT ID:
NCT05950204
Condition:
Acute Lymphoblastic Leukemia
Vitamin d Deficiency
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Vitamin D Deficiency
Calcium, Dietary
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Calcium Carbonate
Calcium
Conditions: Keywords:
Acute Lymphoblastic Leukemia
Bone Turnover Biomarkers
Corticosteroids
Bone Mineral Density
Long-Chain polyunsaturated fatty acids
n-3 fatty acids
Vitamin D
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
ω-3 polyunsaturated fatty acids (DHA and EPA), Vitamin D (cholecalciferol), Calcium (calcium carbonate)
Description:
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.
Arm group label:
Group A
Arm group label:
Group B
Other name:
LCPUFA-ω3
Other name:
Vitamin D
Other name:
Calcium
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.
Criteria for 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
Gender:
All
Minimum age:
5 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Unit of research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
Address:
City:
Mexico City
Zip:
06720
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Maria de Lourdes Barbosa Cortes 33, PhD
Phone:
5514803521
Email:
lulubc@gmail.com
Contact backup:
Last name:
Jorge Maldonado Hernandez, PhD
Phone:
5518433131
Email:
jormh@yahoo.com.mx
Start date:
September 10, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Coordinación de Investigación en Salud, Mexico
Agency class:
Other
Collaborator:
Agency:
Instituto Mexicano del Seguro Social
Agency class:
Other
Source:
Coordinación de Investigación en Salud, Mexico
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05950204
