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Column | Value |
---|---|
Trial registration number | NCT04751669 |
Full text link
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : July 8, 2023, 8 a.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : July 8, 2023, 8 a.m. Source : ClinicalTrials.gov |
Not reported |
Registration date
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-02-12 |
Recruitment status
Last imported at : March 26, 2024, 8 p.m. Source : ClinicalTrials.gov |
Completed |
Study design
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
Allocation
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
Design
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
Masking
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
Inclusion criteria
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
inclusion criteria: informed consent form signed. patients with symptoms compatible with covid-19: cough and fever who not fulfil criteria of hospitalization and will be in outpatient care. positive polymerase chain reaction (pcr) or transcription-mediated amplification (tma) test or rapid antigen test for severe acute respiratory syndrome corona virus-2 (sars-cov-2) or diagnostic test available. age ≥ 18 years availability to meet the requirements of the protocol. |
Exclusion criteria
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
intake of any micronutrient supplement during the month prior to inclusion. patients fulfilling hospitalization criteria. previous allergies to the micronutrient components and excipients. age ≥ 90 years with any comorbidity (diabetes, hypertension, obesity, heart disease, respiratory disease) participation in other research that requires experimental intervention (does not include observational studies) in the previous month before signing the informed consent form. detection by the researcher of lack of knowledge or willingness to participate and comply with all the requirements of the protocol. any other findings that at the discretion of the researcher may compromise protocol performance or significantly influence the interpretation or results of the effects of the nutritional supplement pregnancy or breastfeeding |
Number of arms
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2 |
Funding
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Fundació Institut Germans Trias i Pujol |
Inclusion age min
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Jan. 13, 2023, noon Source : ClinicalTrials.gov |
90 |
Countries
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Spain |
Type of patients
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
Severity scale
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
Total sample size
Last imported at : March 26, 2024, 8 p.m. Source : ClinicalTrials.gov |
252 |
primary outcome
Last imported at : March 26, 2024, 8 p.m. Source : ClinicalTrials.gov |
Incidence of Long Covid.;Need for hospital admission |
Notes
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
Arms
Last imported at : Feb. 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 803, "treatment_name": "Micronutrients", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |