The product being studied is a registered food supplement in Japan, UAE, Kenya, Oman, Cambodia, Mauritius, and Myanmar.
Contract research organization Vedic Lifesciences (Mumbai) has initiated a pilot human clinical trial to determine whether a food supplement can help influence and possibly increase a person's immune response after he or she receives a COVID-19 vaccine.
The product being studied is a registered food supplement in Japan, UAE, Kenya, Oman, Cambodia, Mauritius, and Myanmar. It comprises 5-aminolevulinic acid phosphate and sodium ferrous citrate. According to a Vedic Lifesciences press release, “It has a good history of safe use, which was previously tested in different clinical trials, but it has never been tried together with vaccination for a similar immune application.”
The study is being conducted in subjects who received either the AstraZeneca/Serum Institute’s Covishield vaccine or Bharat Biotech’s Covaxin vaccine. The subjects will be healthy men and women up to age 70, three months after receiving their first vaccine dose. The study excludes people treated with monoclonal antibodies or convalescent plasma, but it does include those who were previously infected with SARS-CoV2 but who fully recovered. The study also excludes subjects taking immune-boosting supplements or foods, including vitamin D.
“The study will compare the Geometric Mean Titer (GMT) of immunoglobulin G (IgG) levels against the SARS Cov2 spike protein, in both the interventional and non-interventional group. Quality of life and safety assessments will be made throughout the study," the comapny states. The study’s ClinicalTrials.gov registry number is NCT05234346.
The company reports that “the pilot study is well on its way and is now expected to meet its recruitment target of 160 completers within three months from first till last subject included (mid June 2022).”
Vedic Lifesciences CEO Jayesh Chaudhary added, “This clinical trial is significant because currently there is little or not enough evidence on supplements that can be used reliably for expediating or boosting the seroconversion after a dose of COVID-19 vaccine.”