INOFOLIC® contains two well documented ingredients: myo - Inositol and folic acid. We will show data for myo - Inositol only or data generated with the combination, the product INOFOLIC®. Thereafter, we will focus on folic acid.
Regarding myo - Inositol
Actually, myo-Inositol is very close to our heart. We provide it every day to our loved ones, to babies in baby milk. The EU commission has re-published several times the report "Report of the Scientific Committee on Food on the Revision of Essential Requirements of Infant Formulae and Follow-on Formulae". The report states on page 73, §2.4: "The Committee proposes a minimum content of myo-Inositol of 4 mg/100 kcal and a maximum content of myo-Inositol of 40 mg/100 kcal for infant formulae, while no limits are suggested for follow-on formulae" (source 1). The inclusion of myo - Inositol is reasoned by "Inositol ... plays an important structural and functional role in signal transduction and metabolic regulation (Aukema and Holub, 1994; LSRO, 1998). Physiologically, Inositol is an essential growth factor, which is readily synthesised in the body, but may need to be provided in the diet under certain conditions" (source 1). If you count a 2000 kcal diet for an adult this corresponds to 0,8 g daily via baby milk as recommendation from the EU authorities in addition to intake by general nutrition.
Let us focus on clinical studies. In an review article pulished 2011 the author states: "several clinical trials have been carried out in order to evaluate the effects of myo - Inositol in pathologic conditions, mainly neuropsychiatric disease (depression, Alzheimer disease, panic disorder) and polycystic ovary syndrome (PCOS) (source 2, 3). The duration of myo - Inositol exposure in these trials ranged from 1 to 12 months. The doses ranged from 4 to 30 g/day" (source 4). Just for comparison, one sachet of INOFOLIC® contains 2 g myo - Inositol. Regarding unwanted side effects the report concludes: "The safety data of the trials report mild side effects such as, nausea and one of flatus and mild insomnia only at 12 g/day or higher. ... Notably, the dosage of 4 g/day of Inositol commonly used in clinics is completely free of side effects". (source 4)
Regarding folic acid
Folate deficiency is associated with a reduction in de novo DNA biosynthesis and impairment of cellular replication: recognised haematologically as macrocytic anaemia. Poor folate status in the peri-conceptual period has been associated with increased risk of neural tube defects (NTD) in the offspring. Poor folate status may lead to hyperhomocysteinaemia, which has been associated with and increased risk of vascular disease. (source 1)
According to the World Health Organisation (WHO), women should take 0.4 mg per day two months before conception and during the first three months of their pregnancy to reduce the risk of a NTD affected pregnancy. (source 5)
Again if we look into baby food - the EU commission has re-published several times the report "Report of the Scientific Committee on Food on the Revision of Essential Requirements of Infant Formulae and Follow-on Formulae". The report states on page page 121 §7.3: "For children aged 1-3 years, the Committee set a tolerable upper intake level for folic acid of 200 μg/day (SCF, 2000b). ... The Committee makes the following recommendation on the folate content of infant formulae and follow-on formulae: as folic acid, minimum 10 μg/100 kcal, maximum 30 μg/100 kcal." (source 1).
By the way, the US National Institute of Health (NIH) has been reviewing: Folic acid is LIKELY SAFE for most people. Most adults do not experience any side effects when consuming the recommended amount each day, which is 400 mcg. (source 6)
INOFOLIC® is marketed under several brands in Europe and has been launched in more than 15 European countries with more than 100.000 satisfied patients already.
Sources:
1. http://europa.eu.int/comm/food/fs/sc/scf/index_en.html
2. COSTANTINO D, MINOZZI G, MINOZZI E, GUARALDI C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double- blind trial. Eur Rev Med Pharmacol Sci 2009; 13: 105-110.
3. RIZZO P, RAFFONE E, BENEDETTO V. Effect of the treat- ment with myo-inositol plus folic acid plus mela- tonin in comparison with a treatment with myo-in- ositol plus folic acid on oocyte quality and preg- nancy outcome in IVF cycles. A prospective, clini- cal trial. Eur Rev Med Pharmacol Sci 2010; 14: 555-561.
4. CARLOMAGNO. Inositol safety clinical evidences. Eur Rev Med Pharmacol Sci 2011; 15: 931-936.
5. http://www.ifglobal.org/en/what-we-do/prevention
6. http://www.nlm.nih.gov/medlineplus/druginfo/natural/1017.html by Copyright © 1995 - 2015 Therapeutic Research Faculty, publishers of Natural Medicines Comprehensive Database, Prescriber’s Letter, Pharmacist’s Letter. All rights reserved. For scientific data on natural medicines, professionals may consult the Professional Version of Natural Medicines Comprehensive Database.