Supplementation with omega-3 fatty acids, vitamin D, and calcium for children with acute lymphoblastic leukemia
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.
NA · Coordinación de Investigación en Salud, Mexico · NCT05950204
This study is testing if giving omega-3 fatty acids, vitamin D, and calcium to children with acute lymphoblastic leukemia can help improve their bone health during treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | Coordinación de Investigación en Salud, Mexico (other gov) |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT05950204 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of omega-3 fatty acids, vitamin D, and calcium supplementation in children diagnosed with acute lymphoblastic leukemia (ALL) who are undergoing treatment. It aims to measure changes in bone turnover biomarkers after 6 and 12 weeks of supplementation, addressing the negative impact of corticosteroids on bone health. The study focuses on the high prevalence of vitamin D deficiency in pediatric ALL patients and the potential role of omega-3 fatty acids in promoting bone health. This is the first randomized controlled trial to investigate the combined effects of these supplements on bone metabolism in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are children with acute lymphoblastic leukemia who are in the maintenance phase of treatment and can swallow capsules.
Not a fit: Patients with acute or chronic renal failure, additional pathologies, fish hypersensitivity, or Down's syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve bone health and reduce the risk of osteoporosis in children undergoing treatment for acute lymphoblastic leukemia.
How similar studies have performed: While there is limited research on this specific combination of supplements in pediatric ALL patients, emerging evidence suggests potential benefits of omega-3 fatty acids for bone health.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mexico City
- Unit of research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social — Mexico City, Mexico (RECRUITING)
Study contacts
- Principal investigator: María de Lourdes Barbosa Cortés, PhD — Instituto Mexicano del Seguro Social
- Study coordinator: Maria de Lourdes Barbosa Cortés, PhD
- Email: lulubc@gmail.com
- Phone: 5514803521
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Lymphoblastic Leukemia, Vitamin d Deficiency, Bone Turnover Biomarkers, Corticosteroids, Bone Mineral Density, Long-Chain polyunsaturated fatty acids, n-3 fatty acids, Vitamin D