scholarly journals Evaluation of novel and superior formulation CaroTexTM developed by Biofusion Technology

2019 ◽  
Vol 10 (3) ◽  
pp. 1868-1873
Author(s):  
Sneha Bagle ◽  
Suraj Muke ◽  
Sagar Saha ◽  
Shankarnarayanan Jayakodi ◽  
Arunkanth Krishnakumar ◽  
...  

Per WHO, vitamin A deficiency is a systemic disease affecting cells, organs throughout the body. The gradual depletion of vitamin A stores results in xerophthalmia, night blindness, xerosis etc., reversed by vitamin A therapy. Beta-Carotene, a carotenoid, is the precursor of vitamin A, which cannot be synthesized by the human body. Hence beta carotene formulation has gathered considerable attention in the healthcare industry.  Hydrophobicity of Beta carotene being a major challenge in the formulation, Zeushygia Life Sciences Pvt. Ltd (Telangana India) developed a novel beta carotene formulation, CaroTex, with enhanced bioavailability.  The present study assesses the bioavailability of CaroTex in a rodent model. The animals were divided into 5 groups, Normal Control, Vehicle Control, Standard beta Carotene, Comparator and CaroTex. As rats efficiently convert beta carotene into vitamin A, high dose of beta-carotene (50mg/kg) was given orally for 7 consecutive days. Beta carotene, its metabolic product retinal were measured in rat liver. It was observed that beta carotene concentration in rats fed with CaroTex was about 1.70, 2.55 times higher than Comparator and control respectively whereas the concentration of retinal was the same in all groups. It is evident from this study that novel formulation technology (BioFusion Technology) of CaroTex reflects in relatively higher concentration levels of beta carotene.

2014 ◽  
Vol 84 (Supplement 1) ◽  
pp. 52-59 ◽  
Author(s):  
Sherry A. Tanumihardjo ◽  
Anura V. Kurpad ◽  
Janet R. Hunt

The current use of serum retinol concentrations as a measurement of subclinical vitamin A deficiency is unsatisfactory for many reasons. The best technique available for vitamin A status assessment in humans is the measurement of total body pool size. Pool size is measured by the administration of retinol labelled with stable isotopes of carbon or hydrogen that are safe for human subjects, with subsequent measurement of the dilution of the labelled retinol within the body pool. However, the isotope techniques are time-consuming, technically challenging, and relatively expensive. There is also a need to assess different types of tracers and doses, and to establish clear guidelines for the use and interpretation of this method in different populations. Field-friendly improvements are desirable to encourage the application of this technique in developing countries where the need is greatest for monitoring the risk of vitamin A deficiency, the effectiveness of public health interventions, and the potential of hypervitaminosis due to combined supplement and fortification programs. These techniques should be applied to validate other less technical methods of assessing vitamin A deficiency. Another area of public health relevance for this technique is to understand the bioconversion of β-carotene to vitamin A, and its relation to existing vitamin A status, for future dietary diversification programs.


2017 ◽  
Vol 8 (2) ◽  
pp. 151 ◽  
Author(s):  
Ted H Greiner

Food-based approaches to combat vitamin A deficiency (VAD) continue to be largely ignored by governments and donor agencies. This review deals with common misperceptions as well as constraints that may lay behind this reality. First, high-dose vitamin A capsules provided to preschool age children are no solution for VAD. Second, researchers may assume that it is not possible to standardize foods adequately to study their efficacy in controlled trials. This review summarizes the results of 57 such trials, providing an overview that may assist researchers in making decisions on target groups to study, types of food supplements to provide, quantities, supplementation periods, impacts that are realistic to expect, and sample sizes. Even more complex is to design efficacy trials or impact evaluations of interventions. Again, the paper reviews 40 such trials, providing summary information on approaches, target groups, sample sizes, periods of intervention, and impacts measured using a variety of indicators. There are a number of barriers or constraints that must be planned for and overcome if food-based approaches are to work. This paper reviews several of the most important ones, briefly touching on many of the most effective ways that have been found to overcome them. Food-based approaches can reach all members of the community, are safe for pregnant women, tend to be at least partially sustainable, and confer a wide range of nutritional and other benefits in addition to improving vitamin A status. Food-based approaches are sometimes described as expensive, but this is based on a narrow view. For example, biofortification and dissemination of sweet potatoes cost $9 to $30 per disability-life-year (DALY) gained, while that from VAS was estimated at the estimated cost effectiveness of VAS is $73 per DALY gained. From the community point of view, the economic benefits of food based approaches are likely to subsidize or outweigh their costs.


2021 ◽  
Vol 10 (2) ◽  
pp. 184-190
Author(s):  
Khairun Nisa ◽  
Ryka Marina Walanda

Beta-carotene is converted in the body to vitamin A, a powerful antioxidant that plays an essential role in maintaining healthy eyes, skin, and neurological function. Beta-carotene and other carotenoids have antioxidant activities and are valued for their ability to prevent chronic disease. β-carotene is found in yellow, orange, red, and green fruits. The purpose of this study was to determine the β-carotene in Jongi. Jongi (Dillenia Serrata Thunb.) is an endemic fruit of Sulawesi which contains β-carotene. The samples used in this study were raw jongi and ripe jongi extracted with n-hexane: acetone (1:4). To the samples were analyzed quantitatively using UV-Vis spectrophotometry at a wavelength of 450.00 nm. The results showed that the β-carotene in raw jongi was 0.3554 mg/100 g and the β- carotene in ripe jongi was 1.1841 mg/100 g. Ripe jongi consist of more β-carotene than the raw jongi, hence better as a source of Vitamin A.


2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 130-130
Author(s):  
Sumathi Swaminathan ◽  
Sumithra Selvam ◽  
Agnita Narendra ◽  
Tinku Thomas ◽  
Anil Vasudevan ◽  
...  

Abstract Objectives Vitamin A requirements in early infancy are met only by breast milk intake. It is critical to ensure adequate breast milk vitamin A levels which also helps develop liver stores. The objective of the study was to evaluate the effect of a maternal food-based intervention on breast milk vitamin A content Methods Pregnant women (n = 50; 24 ± 1 week of gestation) were recruited for the randomized study. A 10 g of a green leafy vegetable powder (mint/coriander/curry) providing about 3200 μg β-carotene/day, for a period of 4 months up to 1 month of lactation were provided for intervention arm. Breast milk (BM) retinol concentration and BM volume were assessed. BM retinol and beta-carotene were assayed by HPLC and BM fat by creamatocrit method. BM retinol: fat ratio was calculated. The dose-to-mother deuterium dilution technique was used to estimate BM volume through enrichment of saliva measured by Fourier Transform Infrared Spectroscopy. Total BM retinol content was calculated from BM volume and the BM retinol (including beta-carotene:1 vitamin A RAE = 12 μg β-carotene). Inadequacy of intake was defined as proportion of infants with intake below a requirement of 400 μg RAE/day. Analysis of co-variance was performed after adjusting for age of mother, change in maternal blood retinol from baseline and BM fat, to compare outcomes between intervention and control arm. Results Maternal age, gestational age, socio-demographic characteristics and baseline vitamin A intake were comparable in both arms. Mean BM volume was similar in the 2 arms (676 ± 102 in intervention vs 630 ± 100 ml/day in control). BM retinol content (0.72 ± 0.12 vs 0.64 ± 0.11 μg/mL; P = 0.029) and BM retinol: fat ratio [0.41 (0.31, 0.47) vs 0.29 (0.21, 0.41), P = 0.011] were significantly higher in the intervention arm. The mean total BM retinol content was significantly higher in the intervention (482.2 ± 100.7 vs 406.5 ± 89.2 μg/day; P = 0.015; Cohen's effect size 0.80). Inadequacy of infant vitamin A intake was 14.3% in the intervention arm as against 39.1% in the control arm (P = 0.065). Conclusions The food-based intervention was effective in increasing vitamin A content in breast milk and thereby vitamin A intake in infants. Funding Sources International Atomic Energy Agency.


2020 ◽  
Vol 150 (11) ◽  
pp. 3005-3012
Author(s):  
Shaikh M Ahmad ◽  
M Nazmul Huda ◽  
Rubhana Raqib ◽  
Firdausi Qadri ◽  
Md Jahangir Alam ◽  
...  

ABSTRACT Background Vitamin A (VA) stores are low in early infancy and may impair development of the immune system. Objective This study determined if neonatal VA supplementation (VAS) affects the following: 1) development of regulatory T (Treg) cells; 2) chemokine receptor 9 (CCR9) expression, which directs mucosal targeting of immune cells; and 3) systemic endotoxin exposure as indicated by changed plasma concentrations of soluble CD14 (sCD14). Secondarily, VA status, growth, and systemic inflammation were investigated. Methods In total, 306 Bangladeshi infants were randomly assigned to receive 50,000 IU VA or placebo (PL) within 48 h of birth, and immune function was assessed at 6 wk, 15 wk, and 2 y. Primary outcomes included the following: 1) peripheral blood Treg cells; 2) percentage of Treg, T, and B cells expressing CCR9; and 3) plasma sCD14. Secondary outcomes included the following: 4) VA status measured using the modified relative dose-response (MRDR) test and plasma retinol; 5) infant growth; and 6) plasma C-reactive protein (CRP). Statistical analysis identified group differences and interactions with sex and birthweight. Results VAS increased (P = 0.004) the percentage of CCR9+ Treg cells (13.2 ± 1.37%) relative to PL (9.17 ± 1.15%) in children below the median birthweight but had the opposite effect (P = 0.04) in those with higher birthweight (VA, 9.13 ± 0.89; PL, 12.1 ± 1.31%) at 6 and 15 wk (values are combined mean ± SE). VAS decreased (P = 0.003) plasma sCD14 (1.56 ± 0.025 mg/L) relative to PL (1.67 ± 0.032 mg/L) and decreased (P = 0.034) the prevalence of VA deficiency (2.3%) relative to PL (9.2%) at 2 y. Conclusions Neonatal VAS enhanced mucosal targeting of Treg cells in low-birthweight infants. The decreased systemic exposure to endotoxin and improved VA status at 2 y may have been due to VA-mediated improvements in gut development resulting in improved barrier function and nutrient absorption. This trial was registered at clinicaltrials.gov as NCT01583972 and NCT02027610.


Author(s):  
G Bhanuprakash Reddy ◽  
Raghu Pullakhandam ◽  
Santu Ghosh ◽  
Naveen K Boiroju ◽  
Shalini Tattari ◽  
...  

ABSTRACT Background Biochemical vitamin A deficiency (VAD) is believed to be a serious public health problem (low serum retinol prevalence >20%) in Indian children, justifying universal high-dose vitamin A supplementation (VAS). Objective To evaluate in Indian children younger than 5 y the risk of biochemical VAD from the Comprehensive National Nutrition Survey, as well as dietary vitamin A inadequacy and excess over the tolerable upper limit of intake (TUL) from national and subnational surveys, factoring in fortification and VAS. Methods Child serum retinol data, corrected for inflammation, were examined to evaluate national- and state-level prevalence of VAD. Simultaneously, dietary intakes from the National Sample Survey Office and the National Nutrition Monitoring Bureau were examined for risk of dietary vitamin A deficiency against its average requirement (AR) derived for Indian children. Theoretical estimates of risk reduction with oil and milk vitamin A fortification were evaluated along with the risk of exceeding the TUL, as well as when combined with intake from VAS. Results The national prevalence of biochemical VAD measured in 9563 children was 15.7% (95% CI: 15.2%, 16.3%), and only 3 states had prevalence significantly >20%. The AR of vitamin A was 198 and 191 µg/d for boys and girls; the risk of dietary inadequacy was ∼70%, which reduced to 25% with oil and milk fortification. Then, the risk of exceeding the TUL was 2% and 1% in 1- to 3-y-old and 4- to 5-y-old children, respectively, but when the VAS dose was added to this intake in a cumulative 6-mo framework, the risk of exceeding the TUL rose to 30% and 8%, respectively. Conclusion The national prevalence of VAD risk is below 20% in Indian children. Because there is risk of excess intake with food fortification and VAS, serious consideration should be given to a targeted approach in place of the universal VAS program in India.


1970 ◽  
Vol 29 (2) ◽  
Author(s):  
Kumale Tolesa Daba ◽  
Dagmawit Kifle ◽  
Jafer Kedir Ababora

BACKGROUND: Diet induced vitamin A deficiency is less commonly seen in otherwise healthy adults, due to large store of vitamin A in the body. Night blindness is the commonest manifestation of vitamin A deficiency in adults, whereas Keratomalacia is a rare manifestation.CASE REPORT: A 27 years old Ethiopian woman came to Jimma University Department of Ohthalmology with a compliant of protrusion of the globe content of both eyes within a week, after having redness and fear of light of both eyes for 2 months. She was a mother of twins and had low socioeconomic status. On general examination, she was cachectic with enlarged parotid glands. On ocular examination, she was bilaterally blind and had dry ocularsurface. There was bilaterally melted cornea with prolapsed uveal tissue. After several investigations she was diagnosed as bilateral Keratomalacia (stage X3B) secondary to diet induced vitamin A deficiency. She was supplemented with vitamin A and other nutritional supplementation. Topical lubricating drops and ointments were administered. Finally, conjunctival flap was done to preserve the globe.CONCLUSION: Although it is rare, treating physicians should be aware of the occurrence of Keratomalacia in adults which is potentially blinding. Early recognition and treatment of vitamin A deficiency at the stage of night blindness is essential in reducing blindness caused by Keratomalacia.


2018 ◽  
Vol 34 (7-8) ◽  
pp. 197-208
Author(s):  
R M Nurrachim ◽  
Ali Usman ◽  
Sjarif Hidajat ◽  
Dedi Subardja ◽  
Tina Agoestina ◽  
...  

Vitamin A deficiency is a major cause of blindness and severe morbidity and mortality in young children. Supplementation of vitamin A in the community might reduce child mortality rates. The safety of high dose of vitamin A administered to neonates is not clear. We randomized 2058 neonates to receive either a single dose of 50 000 IU oral vitamin A (n=l031) or placebo (n=l027). Bulging fontanel and head circumference were assessed before and throughout 48 hours following dosing. Cranial ultrasound examination was carried out in 972 infants before and 24 hours after dosing to rule out intracranial hemorrhage and determine resistive index (Rl) of the anterior cerebral artery. Slight bulging fontanel occurred in 2. 7% and 4.4% of the infants at 24 hours. Moderate bulging fontanel was seen in 0.1% of study group, no severe bulging was observed. At 48 hours slight bulging fontanel was observed in 2.4% of control group and 4.5% in study group. No intracranial hemorrhage was found. Mean RI values were normal in both groups at baseline or 24 hours. Bulging fontanel was not associated with increased signs or symptom, or with increase in RI. Single oral dose of 50 000 vitamin A may cause a small increase in intracranial volume in a small proportion of infants, without increase in intracranial pressure.


2011 ◽  
Vol 6 ◽  
pp. CMRH.S8372 ◽  
Author(s):  
Joel S. Goldberg

Retinoic acids (13-cis and 13-trans) are known teratogens, and their precursor is retinol, a form of vitamin A. In 1995, Rothman et al demonstrated an association between excessive vitamin A, > 10,000 IU/day, during the first trimester of pregnancy and teratogenic effects, particularly in the central nervous system. However, vitamin A deficiency has long been known to be deleterious to the mother and fetus. Therefore, there may be a narrow therapeutic ratio for vitamin A during pregnancy that has not previously been fully appreciated. Neurodevelopmental disorders may not be apparent by macroscopic brain examination or imaging, and proving the existence of a behavioral teratogen is not straightforward. However, an excess of retinoic acid and some neurodevelopmental disorders are both associated with abnormalities in cerebellar morphology. Physical and chemical evidence strongly supports the notion that beta carotene crosses the placenta and is metabolized to retinol. Only very limited amounts of beta carotene are stored in fetal fat cells as evidenced by the fact that maternal fat is yellow from beta carotene, whereas non-brown neonatal fat is white. Furthermore, newborns of carotenemic mothers do not share the yellow complexion of their mothers. The excess 13-trans retinoic acid derived from metabolized beta carotene in the fetus increases the concentration of the more teratogenic 13-cis retinoic acid since the isomerization equilibrium is shifted to the left. Therefore, this paper proposes that consideration be given to monitoring all potential sources of fetal 13-cis and 13-trans retinoic acid, including nutritional supplements, dietary retinol, and beta carotene, particularly in the first trimester of pregnancy.


2002 ◽  
Vol 132 (9) ◽  
pp. 2845S-2850S ◽  
Author(s):  
Alfred Sommer ◽  
Frances R. Davidson

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