No abstract

Background The fat-soluble K vitamins K1 and K2 play an essential role in the blood coagulation cascade and are made available predominantly through selective dietary intakes. They are less known for their nonessential roles in a family of vitamin K–dependent proteins that promote various functions of organs and systems in the body. A lack of vitamin K can characterize vitamin and nutritional element insufficiency, which is different from a clinically apparent vitamin deficiency. Objective This epidemiological study evaluated the nutritional status of vitamin K in a sample of the Indian population and vitamin K content in staple Indian foods. Methods Serum levels of vitamin K1 and vitamin K2 in the form of menaquinone-7 (MK-7) were assessed via high-performance liquid chromatography coupled with fluorescence detection in 209 patients with type 2 diabetes, 50 healthy volunteers, and common staple foods in India. Results After comparing populations with high and low serum vitamin K levels from various geographical regions, our results indicated that the sample of healthy Indian individuals and the sample of Indian patients with type 2 diabetes had low (insufficient) levels of vitamin K2 (MK-7; range 0.3-0.4 ng/mL). No significant differences existed in vitamin K1–related and MK-7–related values between healthy male and female subjects, between male and female subjects with diabetes, and between the healthy sample and the sample of patients with diabetes. The staple, commonly consumed Indian foods that were tested in this study had undetectable levels of vitamin K2, while levels of vitamin K1 varied widely (range 0-37 µg/100 g). Conclusions Based on our sample’s low serum levels of vitamin K2 (MK-7) as well as the low levels of vitamin K2 in their typical diet, we propose that the general Indian population could benefit from the consumption of vitamin K2 in the form of MK-7 supplements. Trial Registration Clinical Trials Registry - India CTRI/2019/05/014246; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=21660&EncHid=&userName=014246; Clinical Trials Registry - India CTRI/2019/03/018278; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=32349&EncHid=&userName=018278

Objective: The study was conducted to evaluate the safety, efficacy and tolerability of Barrier Foam Dressing (BFD) combined with ammonium Polyquaternary compoundpoly(DADMAC) with regard to effect on wound characteristics i.e., size, discharge, granulation; extent of dressing breakthrough in exuding wounds, pain and time to wound closure by epithelization or readiness for secondary suturing or skin grafting. Material and Methods:The study was an open labeled single center trial of 30 patients with wound or wounds of different etiologies. The patients satisfying inclusion and exclusion criteria as specified in the protocol approved by the Ethical Committee, were enrolled. The wound was evaluated on the basis of size, discharge and granulation at baseline and on every 8th day along with wound photograph till the end point. Microbial analysis of the wound swab and pain score (using Visual Analog Scale -VAS) was recorded at baseline and at the end point of study. Improvement in wound healing was observed by contraction of wound, reduction in exudate, wound debridement and as wound epithelisation, or granulation tissue formation that makes the wound ready to receive a skin graft.Results: BFD was observed to have good ability to absorb wound exudate, help separation of necrotic tissue making debridement easier. Minimal adherence was noticed while removing the dressing. There was no need of any topical antimicrobial along with this dressing. Biochemical and microbiological variables also exhibited the safety and efficacy of this dressing. Its application on skin surface was well tolerated without side effects or local reaction by all except one of the patients. Conclusion:The BFD can be used as a primary dressing for various types of wounds and has favorable influence on wound healing process with good tolerance.

Objective: To evaluate the activity and tolerability of a probiotic mix of Bacillus subtilis HU58 plus Bacillus coagulans SC208 and Bacillus coagulans SC208 alone compared with placebo in a group of 75 patients suffering from Antibiotic Associated Diarrhea (AAD). Materials and Methods:An open labeled placebo-controlled trial was conducted for Bacillus subtilis HU58 + Bacillus coagulans SC208 in combination and Bacillus coagulans SC208 alone in patients suffering from AAD. Stool consistency was estimated according to Bristol Stool Chart (BSC) and was recorded at baseline, 3 rd day, 7 th day and on 15 th day along with other symptoms like abdominal pain, bloating and flatulence. All enrolled patients were orally administered either a cocktail of Bacillus subtilis HU58 + Bacillus coagulans SC208 (3 X 10 9 CFU/Cap), or Bacillus coagulans SC208 (2 X 10 9 CFU/ Cap) alone or placebo for 7 days. Blood investigations were done at baseline, 3 rd and 7 th day. A final follow up was done on 15 th day. This study was approved by an Independent Ethics Committee and registered with Clinical Trial Registry of India. A written Informed Consent Form was obtained from the patients before enrollment.Results: Patients (n=75) were randomly allocated in three groups; Group A(n=25), received a combination of Bacillus subtilis HU58 + Bacillus coagulans SC208, Group B(n=25) received Bacillus coagulans SC208 alone and Group C (n=25) received the placebo. The Bristol stool scale (Figure 1) which classifies human stool into seven categories was used to measure the consistency of stool during the study. Statistically significant improvement in stool consistency was seen in both the probiotic groups (p<0.0001) as compared to the placebo (p<0.0799). Stool consistency at baseline in all groups was at scale of 6-7. Improvement was observed in Group A (scale 3) and Group B (scale 5). No reduction of scores was observed in group C (scale 7) till 15 th day. The other symptoms like pain in abdomen, bloating and flatulence were also reduced in both group A and group B as compared to group C. Conclusion:Improvement in stool frequency and consistency along with symptoms like pain in abdomen, bloating and flatulence was found in individuals in group A and group B. Data of patients in group A and group B was found to be statistically significant (p value< 0.0001) compared to group C. It was also found that patients receiving the combination of Bacillus subtilis HU58 + Bacillus coagulans SC208 experienced much better relief in terms of stool frequency and consistency along with pain in abdomen, bloating and flatulence than patients receiving only the Bacillus coagulans SC208 strain. This comparison, however, needs to be further studied in detail by conducting double blind randomized study in larger sample size.

BACKGROUND The fat-soluble K vitamins K1 and K2 are well recognized and exert an essential biological role in the blood coagulation cascade. However, vitamin K is less known for its non-essential roles in participating in the growing family of vitamin K-dependent proteins that promote various functions of organs and systems in the body, sustaining health and preventing disease. These less well-known actions depend on the availability of vitamin K for non-essential multi-tasking functions. This fat-soluble vitamin is available predominantly through selective dietary intakes, and its presence is absent or very low in many diets. The lack of vitamin K for non-essential biological functions exemplifies vitamin/nutritional element insufficiency, which is different from a clinically apparent vitamin deficiency. OBJECTIVE The current epidemiological study evaluated the nutritional status of vitamin K in a sample of the Indian population and its content in staple Indian foods. METHODS Serum levels of vitamin K1 and vitamin K2 in the form of MK-7 were assessed by high-performance liquid chromatography (HPLC) coupled with a fluorescence detector in 209 patients with Type 2 diabetes and 50 healthy volunteers and in common, staple foods in India. RESULTS The results indicate that in comparison to populations with high and low serum levels in various geographical regions, the sample of India population of apparently healthy individuals and Type 2 diabetes patients showed low (insufficient) levels of vitamin K2 (menaquinone-7). The staple, commonly consumed Indian foods that were tested in the study showed undetectable content of vitamin K2. CONCLUSIONS The general population could benefit from the consumption of vitamin K2 in the form of MK-7 supplements, with emphasis on patients with diabetes, elevated blood pressure, a harbinger of cardiovascular disease, and compromised immune systems. The results can be extrapolated world-wide. CLINICALTRIAL CTRI 2019/05/014246