Folic Acid Deficiency

NORTH READING, Mass.--( BUSINESS WIRE )--Aphios Corporation announced today that it has been granted Japanese Patent No. 7,520,838 for novel compositions to treat folic acid deficiency and morning sickness. The dosage forms have an effective amount of a folic acid, gingerols and shogaols to suppress nausea, relieve gastric distress and promote hematopoiesis. Pregnancy related nausea and vomiting (PRNV) is the most common medical condition during pregnancy. PRNV affects up to 70% of women during their first trimester, and many in the second and third trimester. The most serious form of PRNV is called Hyperemesis gravidarum (HG) that is reported in up to 10% of pregnant women. PRNV and HG affects women's quality of life and exerts a large economic impact on patients, caregivers and society. There are only a few medications approved by the FDA to treat and manage PRNV and HG. Folic acid deficiency can also have a significant impact on the health and welfare of newborns, parents, caregivers and society. Folic acid is necessary and critical to fetal development during pregnancy since it promotes DNA synthesis and cell division, affecting hematopoietic cells. In addition to folic acid, a number of medications that include folic acid have been used in the past to treat this deficiency during pregnancy. These supplements are also associated with nausea and upset stomach. There is thus a need to develop improved formulations which do not cause gastric distress and nausea. According to Dr. Trevor P. Castor, inventor of the patent, “These novel compositions impact high unmet needs to manage pregnancy related nausea and vomiting without synthetic drugs, while improving the health of the fetus and mother with folic acid supplements, managing any resulting gastric distress and improving hemostasis that is accomplished by both gingerols/shogaols and folic acid supplements.” About Aphios Corporation: Aphios is an emerging growth, green biotechnology company using earth-friendly supercritical fluids and nanotechnologies to develop enabling technology platforms. Based on these platforms and inspired by nature, we are developing enhanced therapeutics to maintain health, improve quality-of-life and treat chronic diseases including certain cancers and Zindol ® for chemotherapy induced nausea and vomiting (CINV), infectious diseases such as HIV/AIDS, influenza and COVID-19, and CNS disorders such as Alzheimer’s disease and opioid addiction in an environmentally sustainable manner.

A team of international researchers has demonstrated, for the first time in a field study, that using folic acid-fortified iodized table salt can prevent multiple severe birth defects. A team of international researchers -- including experts from the University of Central Florida and Emory University -- has demonstrated, for the first time in a field study, that using folic acid-fortified iodized table salt can prevent multiple severe birth defects. The importance of women having enough folic acid in their bodies before and during pregnancy to prevent permanent and life-threatening birth defects, such as spina bifida and anencephaly, has been known for decades. The World Health Organization recommends that all women should take supplement pills with 400 micrograms of folic acid daily, from the moment they begin attempting to conceive through the first three months of pregnancy. Mandatory staple food fortification with folic acid is a cost-effective, safe, and an equitable way to address the issue. In May 2023, the World Health Assembly adopted a resolution promoting food fortification with folic acid to accelerate the slow pace of prevention of spina bifida and other birth defects associated with low maternal folate levels at the time of early pregnancy. Yet approximately 260,000 births worldwide -- about 20 per every 10,000 births -- are still affected by spina bifida and anencephaly, contributing to a high number of stillbirths, elective pregnancy terminations, and deaths of infants and young children. The problem While folic acid has been added through mandatory staple grain food fortification in about 65 countries, including the United States, more than 100 countries have yet to implement fortification due to challenges that include limited capacity for large-scale fortification of staple grains in these regions or lack of political will. A solution A new study published Friday by JAMA Network Open showed that a solution is not only possible, many people already have it on their kitchen tables. The clinical trial showed that mixing folic acid to commercially available iodized table salt, based on the existing average daily consumption of salt, increased serum folate levels among participants to levels needed for prevention of spina bifida and anencephaly. The increase was significant, a 3.7-fold improvement before and after a four-month period of using the study salt with iodine and folic acid. "We proved that folic acid can get into the blood through salt. Hopefully countries that have not already implemented fortification programs can now look at their infrastructures and realize that salt fortification is cheap and it's really easy to add in the amount of folic acid needed to save lives," says Jogi Pattisapu, MD, the study's lead author and a neurosurgeon from UCF's College of Medicine. "It might just turn the salt a little yellow, but the participants did not mind and we know it works. What we need now is action." Why it matters Pattisapu credits the study's successful outcome to the collaborative nature of the research team, specifically the efforts and expertise of researchers from Emory University's Rollins School of Public Health and the colleagues from multiple institutions in India, who co-led the study and recruited and monitored the 83 non-pregnant women -- who were between the ages of 18-45, from four different villages in southern India -- who consumed the folic acid-fortified salt as part of their regular diet during a four-month period in 2022. India has a high prevalence of spina bifida and anencephaly. "Work was done there, by the Indian team, for their cause," Pattisapu says. "That was very important, and it is a powerful message." Even though food fortification is mandatory in the United States, the researchers say the impact of this new study could be felt globally in countries with successful salt iodization programs. "This is a global goodwill involving the health of mothers and babies. We are making sure we apply the knowledge we have," says Vijaya Kancherla, an associate professor in the Department of Epidemiology at Rollins. "These are preventable birth defects and once it happens, you cannot cure it. Surgeries and clinical care are expensive and largely not available in low- and middle-income countries. Due to that, most babies with spina bifida die globally. So, it is a human rights issue that everyone should be worried about and should strive to find alternate solutions that prevent these conditions from occurring in the first place, no matter where one is born. We show that salt has the potential to close the prevention gap now." The researchers also made it clear the study does not promote salt intake, but rather adding the necessary amount of folic acid to the table salt that residents of these regions are already consuming. If the average daily salt consumption is reduced in these regions, the concentration of folic acid would simply be increased, to meet the need. This approach is already used in grain fortification program. The researchers said at least 50 percent of the current global spina bifida cases would be prevented if the major, already existing iodized salt programs took the simple step of adding folic acid. "We now know folic acid fortification of iodized salt can prevent folate deficiency that causes spina bifida," says Godfrey Oakley Jr., MD, director of the Center for Spina Bifida Prevention at Rollins. "The stage is now set for a rapid acceleration of prevention of these birth defects in many countries"

A new study has found high rates of anemia among patients in the Irish health system, while screening for common causes was found to be low. A new study by researchers at University of Limerick in Ireland has found high rates of anaemia among patients in the Irish health system, while screening for common causes was found to be low. The research study carried out by a team at University of Limerick School of Medicine found that substantial numbers of men and women in the health system had anaemia, the presence of which is strongly associated with high rates of hospitalisation, death, and poor quality of life. Anaemia (a low level of haemoglobin in the body) is a common but treatable condition that predicts adverse clinical outcomes. It affects nearly two billion people across the globe and is the third-leading cause of years with lived disability in the world. While the study revealed a high burden of patients with the condition, it found that there were relatively low rates of screening for treatable causes of anaemia, including deficiencies in vitamin B12, folate, and iron, which highlights an important gap in care delivery programs and emphasises the need for quality improvement initiatives. Prior to the large population-based study, the prevalence of anaemia and information on its underlying causes was largely unknown as data at the national or regional level was limited. The research, published in the journal BJGP Open, is the largest study ever to explore the burden of anaemia and the extent of investigation for underlying common causes in Ireland. The study found that 12% of Irish patients had anaemia with 1 in 8 women (13.2%) affected and 1 in 10 men (10.5%). Most of these patients were found to have had mild anaemia (9.1% of total), with moderate to severe anaemia present in the remaining 2.9%. The percentage of patients with anaemia was particularly high in elderly patients, and in patients with underlying medical conditions such as kidney disease, diabetes and for patients undergoing treatment in specific clinical settings. Despite the high burden of anaemia, less than 20% of anaemic patients were tested for deficiencies of vitamin B12 and folic acid, and only one third of all patients were screened for iron deficiency during follow-up. Although there was some improvement in screening rates with increasing severity of anaemia, approximately 50% of patients with severe anaemia did not undergo screening. "This is the largest study to address the magnitude of anaemia and the extent to which it is investigated in the Irish health system," according to senior investigator Professor Austin Stack, Foundation Chair of Medicine at UL's School of Medicine and Consultant Nephrologist, University Hospital Limerick. "Our study reveals a significant burden of anaemia that was present in several high-risk groups, including patients with diabetes, chronic kidney disease, and the elderly. The prevalence of anaemia increased exponentially in older men and women, highlighting their increased vulnerability. "Patients with advanced kidney disease had nearly eight-fold higher prevalence compared to patients with normal kidney function. Patients who attended the emergency room, outpatient departments or admitted to hospital were found to be particularly affected, with prevalence ranging from 18 % to 29 %," Professor Stack explained. Anaemia is a condition in which the body does not have enough healthy red blood cells or haemoglobin (an iron-rich protein) to carry oxygen to the cells around the body. Haemoglobin is essential for red blood cells to carry oxygen from the lungs to the rest of the body. When someone suffers from anaemia, the body does not get enough oxygen in the blood, and this can cause tiredness, shortness of breath, and dizziness. The researchers assembled a cohort of 112,181 patients using data from the National Kidney Disease Surveillance System to assess for anaemia and followed them for up to one year to explore the use of screening tests that check for iron deficiency, B12, and folate deficiency. Co-author Dr Leonard Browne, Senior Research Fellow in Biostatistics at the UL School of Medicine, highlighted the low level of screening for treatable causes of anaemia. "What is remarkable is that less than 20% of anaemic patients were screened for vitamin B12 and folate deficiency, and only one third were screened for iron deficiency at three-months follow-up," he explained. "Despite some improvement with increasing severity of anaemia, approximately 50% of patients with severe anaemia did not undergo screening. Indeed, when we followed patients for up to 12 months, screening rates did increase although modestly for B12 and folate deficiency -- 30% -- and doubled for iron deficiency -- 46%. These findings reveal that common causes of anaemia are inadequately tested for in the wider health system especially among high-risk groups." Professor Stack emphasised the importance of screening for and identifying the underlying cause of anaemia. "We found that one in three patients had evidence of absolute iron deficiency, 6.3% had B12 deficiency, and a further 5.8% were folate deficient. All these deficiencies are easily treated in modern day clinical practice leading to significant improvement in the degree of anaemia. This study provides a valuable starting point from which we can begin to understand practice patterns in care delivery and the development of quality improvement programmes in the health system. "Iron deficiency is the main cause of anaemia affecting women more than men. The findings from our study correlate well with the international body of evidence, which shows that investigation of anaemia subtype is uncommon and that the standards of anaemia management vary considerably," Professor Stack added. The research was funded by the Health Research Board (HRB) and Dr Mairéad O'Driscoll, Chief Executive of the HRB said: "Professor Stack's research is a really nice example of how intelligent and targeted secondary-data analysis can make important contributions to our knowledge base. The data-driven insights from his work have obvious potential to inform and improve health service delivery. "The HRB is committed to working with all of our partners to advance the use of primary and secondary data to enhance health policy, to improve healthcare delivery and to drive innovation in our health services."