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Acute Lymphoblastic LeukemiaNCT04488237

Vitamin D and Methotrexate Adverse Effects

An observational study of Acute Lymphoblastic Leukemia, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Since methotrexate toxicity represents a major problem in patients treating with cancer and there are few studies about the role of vitamin D in the pathogenesis of this toxicity, so the aim of the present study is investigation of the effect of vitamin D administration on methotrexate toxicity such as oral… Read more about this study

Who is it for?
Ages 1 year to 12 yearsHealthy volunteers can take part
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
Vitamin D
Type of treatment
Pill or oral medicine
How many people
50 participants
Where
No sites listed yet
Study dates
Sep 2020to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: cases include patients with acute leumphoblastic leukemia recieving methotrexate in treatment protocol

Who may be able to join

  • Patients with acute lymphoblastic leukemia who do not start treatment course with methotrexate.
  • Both sex will be included.
  • Age group (1 -12 years)

Who cannot join

  • Patients with other type of cancer beside ALL.
  • Patients with renal, hepatic or hematological diseases.

Trial locations and contacts

No sites are listed yet.

Magy Ibrahim Anis Rizkallah, Bachelor contact

01282495775 ext. 002

magy_rezkallah@med.aun.edu.eg

About this study

Official title: Effect of Vitamin D Administration on Methotrexate Adverse Effects in Patients With Acute Lymphoblastic Leukemia

Since methotrexate toxicity represents a major problem in patients treating with cancer and there are few studies about the role of vitamin D in the pathogenesis of this toxicity, so the aim of the present study is investigation of the effect of vitamin D administration on methotrexate toxicity such as oral ulcerations, bone marrow toxicity as well as renal and hepatic toxicity also the role of inflammatory mediators and oxidative stress markers in methotrexate toxicity will be evaluated, taking in consideration the dose of leucovorin rescue.

Read the detailed description

Leukemia is a type of blood cancer that affects the body's white blood cells (WBCs). White blood cells help fight infection and protect the body against disease, but in leukemia, some of the white blood cells turn cancerous and don't work as they should. As more cancerous cells form in the blood and bone marrow (spongy tissue inside the bones), there's less room for healthy cells .

The different types of leukemia can be either acute (fast growing) or chronic (slow growing). Acute lymphoblastic leukemia (ALL) happens when the body makes too many lymphoblasts (a type of white blood cell). It's the most common type of childhood cancer.

Treatment outcome of acute leukemia has been improved recently using Methotrexate . Side effects of methotrexate usually in the form of ulcerative stomatitis, leukopenia (lower amount of white blood cells), nausea, abdominal discomfort, and elevated liver and kidney function tests. Identifying risk factors leading to these side effects would be valuable to develop preventive interventions and improve quality of life for these young patients.

Studies revealed a relationship between vitamin D deficiency and adverse reactions of chemotherapy in cancer patients. This vitamin is important in many physiological processes in the body as bone mineralization and immune regulations . A human body produces vitamin D as a response to sun exposure. A person can also boost their vitamin D intake through certain foods or supplements. .

Previous literature showed that receptors for vitamin D expressed in the mucosa and so there is a relationship between vitamin D deficiency and increase inflammation and impairment of mucosa .

Vitamin D is a fat-soluble vitamin that not only regulates calcium absorption and bone metabolism, but can also regulate cell proliferation, differentiation and the immune response, vitamin D insufficiency/deficiency is associated with poor clinical outcome and significantly worse progression free survival of patients from leukemia and lymphoma.

Calcium is the most abundant element in the human body and is essential for life. It has a key role in many physiological processes including skeletal mineralization, muscle contraction, nerve impulse transmission, blood clotting, and hormone secretion . 1, 25-Dihydroxyvitamin D3 the active form of vitamin D plays major role in intestinal calcium absorption, Calcium homeostasis is also regulated by parathyroid hormone.

Patients with acute lymphoblastic leukemia may be at risk of vitamin D deficiency because of impaired vitamin intake and sunlight exposure .

Being tested
Vitamin D
Keywords
methotrexate, vitamin D
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDrug

    oral administration of Vitamin D in patients with acute leukemia treated with methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of vitamin D administration on methotrexate adverse effects in patients with acute lymphoblastic leukemia

    Since methotrexate toxicity represents a major problem in patients treating with cancer and there are few studies about the role of vitamin D in the pathogenesis of this toxicity, so the aim of the present study is investigation of the effect of vitamin D administration on methotrexate toxicity such as oral ulcerations, bone marrow toxicity as well as renal and hepatic toxicity also the role of inflammatory mediators and oxidative stress markers in methotrexate toxicity will be evaluated, taking in consideration the dose of leucovorin rescue.

    Measured: 1 to 2 years according to the availability of the cases

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study startSep 2020 (estimated)
  3. Primary completionSep 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04488237
Sponsor's protocol ID
MTX side effects and VitD
Status last verified
Jul 2020
First submitted
23 Jul 2020
Last updated
27 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hunger SP, Lu X, Devidas M, Camitta BM, Gaynon PS, Winick NJ, Reaman GH, Carroll WL. Improved survival for children and adolescents with acute lymphoblastic leukemia between 1990 and 2005: a report from the children's oncology group. J Clin Oncol. 2012 May 10;30(14):1663-9. doi: 10.1200/JCO.2011.37.8018. Epub 2012 Mar 12.

    PubMed 22412151

  • Anand A, Singh S, Sonkar AA, Husain N, Singh KR, Singh S, Kushwaha JK. Expression of vitamin D receptor and vitamin D status in patients with oral neoplasms and effect of vitamin D supplementation on quality of life in advanced cancer treatment. Contemp Oncol (Pozn). 2017;21(2):145-151. doi: 10.5114/wo.2017.68623. Epub 2017 Jun 30.

    PubMed 28947884

  • Oosterom N, Dirks NF, Heil SG, de Jonge R, Tissing WJE, Pieters R, van den Heuvel-Eibrink MM, Heijboer AC, Pluijm SMF. A decrease in vitamin D levels is associated with methotrexate-induced oral mucositis in children with acute lymphoblastic leukemia. Support Care Cancer. 2019 Jan;27(1):183-190. doi: 10.1007/s00520-018-4312-0. Epub 2018 Jun 19.

    PubMed 29922939

  • Lalla RV, Choquette LE, Feinn RS, Zawistowski H, Latortue MC, Kelly ET, Baccaglini L. Multivitamin therapy for recurrent aphthous stomatitis: a randomized, double-masked, placebo-controlled trial. J Am Dent Assoc. 2012 Apr;143(4):370-6. doi: 10.14219/jada.archive.2012.0179.

    PubMed 22467697

  • Crew KD, Shane E, Cremers S, McMahon DJ, Irani D, Hershman DL. High prevalence of vitamin D deficiency despite supplementation in premenopausal women with breast cancer undergoing adjuvant chemotherapy. J Clin Oncol. 2009 May 1;27(13):2151-6. doi: 10.1200/JCO.2008.19.6162. Epub 2009 Apr 6.

    PubMed 19349547

  • Fakih MG, Trump DL, Johnson CS, Tian L, Muindi J, Sunga AY. Chemotherapy is linked to severe vitamin D deficiency in patients with colorectal cancer. Int J Colorectal Dis. 2009 Feb;24(2):219-24. doi: 10.1007/s00384-008-0593-y. Epub 2008 Oct 2.

    PubMed 18830610

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Lymphoblastic Leukemia, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Magy Ibrahim Anis Rizkallah, Bachelor (01282495775 ext. 002, magy_rezkallah@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of vitamin D administration on methotrexate adverse effects in patients with acute lymphoblastic leukemia (time frame: 1 to 2 years according to the availability of the cases). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04488237, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.

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Vitamin D and Methotrexate Adverse Effects | AzTrials