Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period.

BACKGROUND: Postpartum iron deficiency anemia (PPIDA) is highly prevalent in developing countries where it constitutes an important cause of maternal morbidity and mortality. Potential determinants of PPIDA are prepartum iron deficiency or iron deficiency anemia in association with severe blood loss during delivery. We investigated the efficacy of oral Sucrosomial® iron for recover from mild-to-moderate PPIDA. METHODS: This pilot study was conducted in three medical centers in Romania. Adult women (≥ 18y) with mild (hemoglobin [Hb] 9-11 g/dL) or moderate (Hb 7-9 g/dL) PPIDA diagnosed at screening (2-24 h after delivery) were eligible. Women with mild PPIDA received oral Sucrosomial® iron (Pharmanutra, S.p.A, Italy) once daily (30 mg elemental iron per capsule) for 60 days. Those with moderate PPIDA received oral Sucrosomial® iron twice daily (60 mg elemental iron) for 10 days, followed by a 50-day course of oral Sucrosomial® iron once daily (30 mg elemental iron). Laboratory parameters, as well as subjective clinical symptoms using a 3-point Likert Scale, were assessed at baseline and on study days 10, 30 and 60. RESULTS: Sixty anemic women entered the study, but three were missed during follow-up. At day 60, a Hb rise was observed in both groups (+ 3.6 ± 1.5 g/dL; p < 0.01), 81% experienced correction of anemia (Hb ≥ 12 g/dL), 36% achieved a ferritin concentration ≥ 30 ng/mL (p < 0.05), and 54% a transferrin saturation (TSAT) ≥ 20% (p < 0.01). For women still anemic at day 60, mean Hb was close to normality (11.3 ± 0.8 g/dL). Resolution of IDA-associated clinical symptoms was already observed just 10 days after treatment initiation. No patient discontinued treatment due to gastrointestinal adverse events. CONCLUSIONS: Sucrosomial® iron was shown to be potentially effective and well tolerated at treating mild and moderate PPIDA. These results encourage the use of oral Sucrosomial® iron as a treatment option for PPIDA, but larger studies with longer follow-up are warrant.

A Patented Blend Consisting of a Combination of Vitex agnus-castus Extract, Lepidium meyenii (Maca) Extract and Active Folate, a Nutritional Supplement for Improving Fertility in Women.

Background:Statistics from recent years have shown that 40% of infertile couples have a female etiological factor, 40% a male etiology and the remaining 20% a combination of female and male factors. For fertile couples, the chance of getting pregnant is 57% in three months of attempts, 75% in six months, 90% in one year, and 95% in two years. One-third of infertile couples have more than one cause involved in their inability to conceive. In 10-20% of cases, the reason for infertility cannot be determined. Approximately 25% of infertile women have ovulatory dysfunction. Objectives:This research investigates improvements on the fertility of couples following treatment with a daily tablet of the patented blend consisting in a combination of Vitex agnus-castus (Vitex) extract, Lepidium meyenii (Maca) extract and active folate alone or with a gel capsule of vitamin, minerals, oligo-elements plus DHA and EPA Omega 3 fatty acids. Materials and methods:Multicenter prospective interventional study with a duration of 18 months, conducted between June 2016 and December 2017. A total of 189 women were enrolled in the study. Participants were assigned to two treatment groups: group A, consisting of 103 patients who received a daily tablet of the patented blend consisting in a combination of Vitex extract, Maca extract and active folate, and group B, consisting of 86 patients who were given a daily tablet of the patented blend also administered to Group A and a gel capsule of vitamins, minerals, oligo-elements plus DHA and EPA omega 3 fatty acids. Paraclinical tests were conducted upon inclusion in the study and six months after treatment initiation in case of non-pregnancy. Every patient received ovulation kits and ovulation tests were performed on day 14 of the menstrual cycle. Outcomes:Average age of the women was 31.18 years (SD 5.18 years). There was a successful pregnancy rate of 37%, with no difference between the two arms of the study. The number of new pregnancies was relatively constant through the study duration. The number of women with ovulation increased from 10% to 42.9% by the end of the study. During the six-month-period of the study, there were no side effects reported between patients of the two groups. Conclusions:The supplement may be used by women trying to conceive. The patented blend consisting of a combination of Vitex, Maca and active folate regulates the menstrual cycle, stimulates ovulation and increases the likelihood of getting pregnant.