A Phase 3 interventional study of Cholecalciferol in Covid19, Vitamin D and Children, Only, sponsored by Coordinación de Investigación en Salud, Mexico. Completed at 1 site in Mexico. Open to participants aged 1 Month to 17 Years. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Coordinación de Investigación en Salud, Mexico · Phase 3, Interventional, and Treatment
Open controlled clinical trial. Hospitalized pediatric patients with COVID-19 will be included. Upon admission to hospital serum determination of vitamin D, interleukins, ferritin and Dimer D will be performed. Subsequently, randomization will be performed to identify which group the patient belongs. Adverse effects will be evaluated on a daily basis. Serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken at the beginning of hospitalization and on the 7th day after admission. It will be recorded if the patient presents deterioration of the respiratory function that requires endotracheal intubation and / or admission to intensive care and / or if he dies, and at what time of hospitalization does this outcome occur. The study will culminate when the patient is discharged from hospitalization.
Hospitalized pediatric patients with COVID-19 will be included. The diagnosis of COVID-19 performed through RT-PCR. Upon admission to hospital, a serum determination of Vitamin D, interleukins, ferritin and dimer-D will be performed. Subsequently, randomization will be performed to identify which group the patient belongs to. In case of being in the vitamin D group, in children under 12 months they will be given 1000U and in children over 12 months they will be given 2000U every 24 hours orally. Adverse effects will be evaluated on a daily basis. Subsequently, serum levels of interleukin (IL) -2, 6, 7,10, ferritin and dimer-D will be taken on day 7 of admission. It will be recorded if the patient presents deterioration of the respiratory function that requires endotracheal intubation and / or admission to intensive care and / or if he dies, and at what time of hospitalization does this outcome occur. The study will culminate when the patient is discharged from hospitalization. On the day of hospital discharge, a blood sample will be taken to determine vitamin D.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 45 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Coordinación de Investigación en Salud, Mexico is the lead sponsor of 95 studies on the registry; 17 are open to participants now.
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Exclusion criteria
Children under 12 months they will be given 1000U and in children over 12 months they will be given 2000U every 24 hours orally during hospitalization
Drug: Cholecalciferol
No intervention
1000U or 2000U every 24 hours orally
Also known as: vitamin D
INTERLEUKINS (IL-2,6,7,10) (pg/ml)
Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization.
Time frame: 7 days
FERRITIN (ng/ml)
Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization.
Time frame: 7 days
DIMER-D
Taken on admission of the patient to hospitalization (through venipuncture measured by an in-vitro diagnostic enzyme immunoassay (ELISA) for quantitative determination) and on day 7 of hospitalization.
Time frame: 7 days
Vitamin D (ng/ml)
determination of 25-hydroxy-Vitamin D in human serum
Time frame: the beginning and through study completion, an average of 21 days
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Coordinación de Investigación en Salud, Mexico