Effect of Supplementation With ω-3 Fatty Acids, Vitamin D and Calcium in Patients With Acute Lymphoblastic Leukemia.
NCT ID: NCT05950204
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-09-10
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Group A
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
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.
Group B
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Added pathology
* Fish Hypersensitivity
* Down´s Syndrome
5 Years
17 Years
ALL
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Coordinación de Investigación en Salud, Mexico
OTHER_GOV
Responsible Party
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María de Lourdes Barbosa Cortés
Associated researcher
Principal Investigators
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María de Lourdes Barbosa Cortés, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Locations
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Unit of research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-785-021
Identifier Type: -
Identifier Source: org_study_id
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