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All Studies   Meta Analysis    Recent:   

Effect of vitamin D supplementation versus placebo on recovery delay among COVID-19 Tunisian patients: a randomized-controlled clinical trial

Jul 2022  
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Recovery 8% Improvement Relative Risk Viral clearance -58% Vitamin D  Abroug et al.  LATE TREATMENT  RCT  LONG COVID Does vitamin D reduce the risk of long COVID (PASC)? RCT 117 patients in Tunisia (May - August 2020) Worse viral clearance with vitamin D (p=0.015) c19early.org Abroug et al., Trials, July 2022 Favorsvitamin D Favorscontrol 0 0.5 1 1.5 2+
Vitamin D for COVID-19
8th treatment shown to reduce risk in October 2020
 
*, now with p < 0.00000000001 from 122 studies, recognized in 9 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,800+ studies for 95 treatments. c19early.org
Long COVID RCT with mostly asymptomatic patients that remained PCR positive for 14 days, showing slower viral conversion with treatment. Authors report "a 30-day follow-up of our patients showed that a long-lasting COVID-19 was noted in 34.5% of patients who received vitamin D and in 38.9% of patients who belonged to the placebo group", however no number of the reported group sizes matches these percentages. Authors do not define "long-lasting COVID-19" which does not match the viral clearance at 30 days shown in Figure 2, and is also unexpected in terms of symptoms according to the baseline symptomatic status. Details and timing of PCR tests are not provided. According to Figure 3, testing appears to have been sporadic - for example ~23 treatment patients remain PCR+ at day 40, however no more than one unique Ct value per day is shown.
Cholecalciferol was used in this study. Meta analysis shows that late stage treatment with calcitriol / calcifediol (or paricalcitol, alfacalcidol, etc.) is more effective than cholecalciferol: 69% [47‑82%] lower risk vs. 39% [27‑49%] lower risk. Cholecalciferol requires two hydroxylation steps to become activated - first in the liver to calcifediol, then in the kidney to calcitriol. Calcitriol, paricalcitol, and alfacalcidol are active vitamin D analogs that do not require conversion. This allows them to have more rapid onset of action compared to cholecalciferol. The time delay for cholecalciferol to increase serum calcifediol levels can be 2-3 days, and the delay for converting calcifediol to active calcitriol can be up to 7 days.
Bolus treatment is less effective. Pharmacokinetics and the potential side effects of high bolus doses suggest that ongoing treatment spread over time is more appropriate. Research has confirmed that lower dose regular treatment with vitamin D is more effective than intermittent high-dose bolus treatment for various conditions, including rickets and acute respiratory infections1,2. The biological mechanisms supporting these findings involve the induction of enzymes such as 24-hydroxylase and fibroblast growth factor 23 (FGF23) by high-dose bolus treatments. These enzymes play roles in inactivating vitamin D, which can paradoxically reduce levels of activated vitamin D and suppress its activation for extended periods post-dosage. Evidence indicates that 24-hydroxylase activity may remain elevated for several weeks following a bolus dose, leading to reduced levels of the activated form of vitamin D. Additionally, FGF23 levels can increase for at least three months after a large bolus dose, which also contributes to the suppression of vitamin D activation1.
Viral load measured by PCR may not accurately reflect infectious virus measured by viral culture. Porter et al. show that viral load early in infection was correlated with infectious virus, but viral load late in infection could be high even with low or undetectable infectious virus. Assessing viral load later in infection may underestimate reductions in infectious virus with treatment.
risk of no recovery, 8.5% lower, RR 0.92, p = 0.85, treatment 20 of 57 (35.1%), control 23 of 60 (38.3%), NNT 31, approximate, reported percentages do not match group sizes, day 30.
risk of no viral clearance, 58.0% higher, HR 1.58, p = 0.01, treatment 57, control 60, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Abroug et al., 21 Jul 2022, Randomized Controlled Trial, placebo-controlled, Tunisia, peer-reviewed, mean age 42.7, 16 authors, study period May 2020 - August 2020, dosage 200,000IU single dose, trial NCT04883203 (history). Contact: hela-abr@hotmail.com.
This PaperVitamin DAll
Effect of vitamin D supplementation versus placebo on recovery delay among COVID-19 Tunisian patients: a randomized-controlled clinical trial
Hela Abroug, Amani Maatouk, Cyrine Bennasrallah, Wafa Dhouib, Manel Ben Fredj, Imen Zemni, Meriem Kacem, Salma Mhalla, Sarra Nouira, Manel Ben Belgacem, Aymen Nasri, Rim Klii, Chawki Loussaief, Nissaf Ben Alya, Ines Bouanene, Asma Belguith Sriha
Trials, doi:10.1186/s13063-023-07114-5
Introduction The present study aimed to determine the impact of vitamin D supplementation (VDs) on recovery delay among COVID-19 patients. Methods We performed a randomized controlled clinical trial at the national COVID-19 containment center in Monastir (Tunisia), from May to August 2020. Simple randomization was done in a 1:1 allocation ratio. We included patients aged more than 18 years who had confirmed reverse transcription-polymerase chain reaction (RT-PCR) and who remained positive on the 14th day. The intervention group received VDs (200,000 IU/1 ml of cholecalciferol); the control group received a placebo treatment (physiological saline (1 ml)). We measured the recovery delay and the cycle threshold (Ct) values in RT-PCR for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The logrank test and hazard ratios (HR) were calculated. Results A total of 117 patients were enrolled. The mean age was 42.7 years (SD 14). Males represented 55.6%. The median duration of viral RNA conversion was 37 days (95% confidence interval (CI): 29-45.50) in the intervention group and 28 days (95% CI: 23-39) in the placebo group (p=0.010). HR was 1.58 (95% CI: 1.09-2.29, p=0.015). Ct values revealed a stable trend over time in both groups. Conclusion VDs was not associated with a shortened recovery delay when given to patients for whom the RT-PCR remained positive on the 14th day.
Authors' contributions Declarations Ethics approval and consent to participate This study was approved by the Human Subjects Protection Tunisia center (TN2020-NAT-INS-40) and by ClinicalTrial.gov with approval numberClinicalTrials.gov ID: NCT04883203. The research ethical considerations were respected including free, informed, written, clear and loyal consent, confidentiality, protection, and assistance Consent for publication Not applicable. Competing interests The authors declare that they have no competing interests. • fast, convenient online submission • thorough peer review by experienced researchers in your field • rapid publication on acceptance • support for research data, including large and complex data types • gold Open Access which fosters wider collaboration and increased citations maximum visibility for your research: over 100M website views per year • At BMC, research is always in progress. Learn more biomedcentral.com/submissions Ready to submit your research Ready to submit your research ? Choose BMC and benefit from: ? Choose BMC and benefit from: Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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