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Tel : +995 32 214 27 33
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MEGASHELCAL PDF Print E-mail

MEGASHELCAL

OBJECTIVE OF THE PRODUCT:

Fulfill dietary requirement of Pregnant Women for incorporated ingredients

PRODUCT POSITIONING:

Pregnant Women

RATIONALE FOR COMBIPACK:

Pregnant women need all the above ingredients and all these ingredients cannot be packaged into one formulation. Supplying all the ingredients in a combipack will ensure that all the ingredients are consumed with minimum logistics problem for the pregnant woman.

RATIONALE FOR THE INGREDIENTS:

Formula A: Fish Oil containing DHA & EPA

Fish oil supplementation has been shown in a number of clinical trials and studies to be beneficial to pregnant women. The relative ratios of DHA: EPA for pregnant women have been in the range from 4.3:1 to 2:1. Megashelcal contains them in the ratio of 4:1 to provide the maximum possible benefits of DHA.

Formula B:

Elemental Calcium…. 500mg

Vitamin D-6.25 mcg,

Magnesium-40 mg,

Manganese-1.80 mg

Zinc -7.50 mg

Copper-1 mg,

Boron- 250 mcg

              

Folic acid has been withdrawn from the composition as all pregnant women are recommended and prescribed an iron formulation which in India is always available along with folic acid.

 

 

Therefore, MEGASHELCAL constitutes a unique product with special value for a pregnant/lactating woman, since it fulfills the pregnant woman’s requirement for essential nutrients such as (i) OMEGA-3-FATTY ACIDS, (ii) CALCIUM (iii) MINERALS and (iv) TRACE ELEMENTS

 


 

2A. ROLE OF MEGASHELCAL IN PREGNANCY & LACTATION

 

2.1.   INTRODUCTION

Maternal nutrition before and during pregnancy may influence the course of the pregnancy, foetal development and the child's health in its early and also adult life. Although all nutrients are needed for normal fetal and postnatal development, low birth weight preterm infants are especially susceptible to nutrient deficiencies like essential fatty acids (EFA) and micronutrients like vitamins and minerals1.

There are number of evidences support that supplementation of specific vitamins, minerals and omega-3 fatty acids can have a positive impact on maternal health in terms of prevention of pre-eclampsia, miscarriage, preterm birth, low birth-weight, gestational diabetes and also on the long-term health of the baby2.

2.2.   ESSENTIAL FATTY ACIDS (EFA) 3

Recent studies have also confirmed the role of EFAs during pregnancy.

EFA cannot be synthesized in the body but they are required for maintenance of optimal health. There are two classes of polyunsaturated fatty acids (PUFAs)--omega-6 and omega-3. The parent omega-6 fatty acid, linoleic acid (LA) is desaturated in the body to form arachidonic acid while parent omega-3 fatty acid alpha-linolenic acid (ALA) is desaturated by microsomal enzyme system through a series of metabolic steps to form eicosapentaenoic acid (EPA) and decosahexaenoic acid (DHA).

There is a critical role of EFAs and their metabolic products for maintenance of structural and functional integrity of central nervous system and retina. Most of the brain growth is completed by 5-6 years of age. At birth brain weight is 70% of an adult, 15% brain growth occurs during infancy and remaining brain growth is completed during preschool years. DHA is the predominant structural fatty acid in the central nervous system and retina and its availability is crucial for brain development. It is recommended that the pregnant and nursing woman should take at least 2.6 g of omega-3 fatty acids and 100-300 mg of DHA daily to look after the needs of her fetus and suckling infant. The follow-up studies have shown that infants of mothers supplemented with EFAs and DHA had higher mental processing scores, psychomotor development, eye-hand coordination and stereo acuity at 4 years of age. Intake of EFAs and DHA during preschool years may also have a beneficial role in the prevention of attention deficit hyperactivity disorder (ADHD) and enhancing learning capability and academic performance3.

Expert panel convened by NIH / ISSFAL recommended dietary allowances during pregnancy for the omega 3-fatty acids intake which is as follows-

Category

Recommended DHA intake*

Average daily intake

Pregnancy & lactation

300 mg

54 mg

Adult women

220 mg

61 mg

Adult men

220 mg

78 mg

*Expert panel convened by NIH /ISSFAL

(i) Simopoulas AP, et al. J Am Coll Nutr. 1999; 18: 487-489. (ii) Benisek D, et al. J Am Coll Nutr. 1999; 18: 543-44. (iii) Benisek D, et al. Obest Gynecol. 2000; 95: 77S-78S

 

2.3.   VITAMINS & MINERALS4, 5, 6

 

Vitamins and minerals, referred to collectively as micronutrients, have important influences on the health of pregnant women and the growing fetus. They serve essential roles in cellular metabolism, maintenance and growth throughout life. They are also central components of many enzymes and transcription factors. The need for optimum amounts of key micronutrients at critical stages during the peri-ovulatory period and subsequent embryonic and fetal life has become the focus of current research activity. WHO and other medical institutions have recommended dietary allowances (RDA) during pregnancy and lactation for various vitamins and minerals. The process of bone formation requires an adequate and constant supply of nutrients such as calcium, protein, magnesium, and vitamin D. However, there are several other vitamins and minerals needed for metabolic processes related to bone, including manganese, copper, boron, and iron. Some of the important ones are as follows:

 

  1. v: 1000-1500 mg
    1. vVitamin: 200-400 I.U.
    2. v: 40-80 mg
    3. v: 2-2.3 mg
    4. v: 2 mg
    5. v:0.5-10 mg (AI)
    6. v: 10-15 mg

2.3.1.   MAGNESIUM

Magnesium is involved in bone and mineral homeostasis and is important in bone crystal growth and stabilization. It is a cofactor in more than 300 enzymatic reactions and plays a major role in bone cell function and hydroxyapatite crystallization and growth.4 Magnesium deficiency plays a role in osteoporosis. In some studies, magnesium intake has been reported to be positively associated with increased BMD and reduced bone resorption in middle-aged women. 4

RDA of Magnesium: 640-80 mg

2.3.2.     ZINC

It is an essential trace element, plays a critical role in normal growth and development, cellular integrity and many biological functions, including protein synthesis and nucleic acid metabolism. Since all these are involved in cell division and growth, zinc is believed to be important for fetal growth and development. Zinc requirement is increased during pregnancy but the lack of a valid indicator precludes a true estimate of zinc deficiency in pregnancy. The gestational deficiency of zinc can adversely affect the pregnancy outcome. Preliminary human data suggest a beneficial effect of prenatal zinc supplementation trials in particular on infant's neurobehavioral development. In the light of the currently available information, zinc supplementation at therapeutic load (30 mg/day) as it is proposed for the treatment of hormonal skin disorders to adolescents, cannot be toxic8.

RDA of Zinc6: 15 mg

2.3.3.     CALCIUM & Vitamin D3

Calcium is essential for many important physiological processes such as bone growth, development of skeletal structure, cell division, neuronal excitability, neurotransmitter release, muscle contraction, membrane integrity, blood coagulation etc. The body’s requirement for Calcium increases with increasing age. Vitamin D3 is the most important nutrient, which enhances calcium's ability to build and maintain bones.

The mechanisms by which Vitamin D3 maintains normal calcium levels are:

  • Facilitates its absorption by the small intestine
  • Decreases its excretion by the kidney

RDA of Calcium6 in pregnancy/lactation :                   1000-1500 mg

RDA of Vit D6 in pregnancy/lactation :                        200-400 IU

 

2.3.4.     BORON

Boron is an important trace mineral necessary for the proper absorption and utilization of calcium for maintaining bone density.

There is no official RDA for boron. A safe and adequate daily intake is estimated to be between 0.5 (500 mcg) and 10 mg

2.3.5.    MANGANESE

Manganese is a cofactor for glycosyltransferases, which catalyse the transfer of a sugar from a nucleotide-diphosphate sugar to an acceptor molecule. 6 This makes MN essential to several stages in the formation of the glycosaminoglycan chondroitin sulfate. Thus Mn palys an important role in the formation of a) connective and Skeletal tissues (b) growth and reproduction and (c) carbohydrate and lipid metabolism

RDA of Manganese: 2-2.3 mg

       2.3.6     COPPER:

About 25 to 60 % of copper is absorbed through the small intestine. Approximately 90% of copper in      serum is incorporated in to ceruplasmin and rest is bound loosely to albumin and other proteins. In the liver copper binds to metallothionein and secreted with bile. Small amount also excreted in the sweat and urine.

Copper is essential for the synthesis of hemoglobin. Copper protein complex ceruplasmin helps in  transport of iron to transferrin for synthesis of hemoglobin. It is a component of several enzymes like cytochrome oxidase, dehydrogenase.

    

RDA of Copper: 2 mg

 

2B. REFERENCES

  1. 1.Szostak-Wegierek D. Importance of proper nutrition before and during pregnancy. Med Wieku Rozwoj. 2000; 4(3 Suppl 1): 77-88.
  2. 2.Glenville M. Nutritional supplements in pregnancy: commercial push or evidence based? Curr Opin Obstet Gynecol. 2006 Dec; 18(6): 642-7.
  3. 3.Singh M. Essential fatty acids, DHA and human brain. Indian J Pediatr. 2005 Mar; 72(3): 239-42.
  4. 4.A. Prentice. Diet. Nutrition and the prevention of osteoporosis. Public health Nutrition 7(1A); 227-243.
  5. 5.Ashworth CJ, Antipatis C. Micronutrient programming of development throughout gestation. Reproduction. 2001 Oct; 122(4): 527-35.
  6. 6.John H. Beattie and Alison Avenell. Trace Element Nutrition and Bone Metabolism. Nutrition Research Reviews 1992; 5: 167-188.
  7. 7.Favier M, Hininger-Favier. Zinc and pregnancy. Gynecol Obstet Fertil. 2005 Apr; 33(4): 253-8.

 

A. COMPOSITION

(Combipack of Formula A & Formula B)

Formula A: Each soft-gelatin capsule contains

INGREDIENT

AMOUNT

Fish Oil (DHA 40% = 280mg, EPA 10% = 70mg)

700 mg

Excipients

q.s.

Formula B: Each tablet contains

INGREDIENT

AMOUNT

Ca CO3 (from organic source – oyster shell)

1250mg

(= elemental 500mg)

Vitamin D3

250 IU

Zinc

7.50 mg,

Magnesium

40 mg

Manganese

1.80 mg

Copper

1 mg

Boron-

           250 mcg

Excipients

q.s.

3B. OTHER PRODUCT DETAILS

PRODUCT CATEGORY   : Nutritional supplement

PRESENTATION               : Two strips (one of 10 soft-gelatin capsules & one of 10 tablets).

INDICATIONS                    : Nutritional supplementation during pregnancy & lactation.

ADMINISTRATION            : 1 soft-gel capsule and 1 tablet twice a day or as directed by physician

ADVERSE REACTIONS   : It is generally well tolerated.  No known serious adverse effects.

CONTRAINDICATIONS    : Hypersensitivity

 


 

4. CLINICAL REPORTS

 

Nutritional supplements in pregnancy: commercial push or evidence based?

Curr Opin Obstet Gynecol. 2006 Dec; 18(6): 642-7.

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

PURPOSE OF REVIEW: This review examines whether nutritional supplements during pregnancy have a role to play in the health of the mother, outcome of pregnancy or health of the baby. It will put into context the increased use of nutritional supplements in pregnancy and whether there is an evidence base for this supplementation. RECENT FINDINGS: Women are not consuming enough nutrients from their diet alone and food is depleted in many important minerals. There is increasing support that supplementation of specific vitamins, minerals and omega-3 fatty acids can have a positive impact on maternal health in terms of prevention of pre-eclampsia, miscarriage, preterm birth, low birth-weight, gestational diabetes and also on the long-term health of the baby. There are some contradictory findings with antioxidants and prevention of pre-eclampsia, and these are discussed. SUMMARY: With soil depletion, over-farming and transportation of foods over hundreds of miles with loss of nutrients en route, together with the increased use of convenience and fast foods, women can be over-fed, but under-nourished in our modern society. These can lead to nutrient deficiencies which can have an impact on the outcome of pregnancy. Evidence shows that supplementation can play a valuable role in the health of the pregnant mother and her baby. Emphasis must always be on eating a good diet, but given the limitations of the 21st century lifestyle and the nutritional content of food, good quality nutritional supplements should be used during pregnancy in combinations rather than isolated single nutrients.

 

Favier M, Hininger-Favier I.

Zinc and pregnancy.

Gynecol Obstet Fertil. 2005 Apr; 33(4): 253-8.

Service d'obstetrique, gynecologie et medecine de la reproduction, hopital Sud, CHU de Grenoble, BP 217, 38043 Grenoble cedex 09, France. This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Zinc, an essential trace element, plays a critical role in normal growth and development, cellular integrity and many biological functions, including protein synthesis and nucleic acid metabolism. Since all these are involved in cell division and growth, zinc is believed to be important for foetal growth and development. Zinc requirement is increased during pregnancy but the lack of a valid indicator precludes a true estimate of zinc deficiency in pregnancy even in developed countries. This review examines the possibility that a gestational deficiency of zinc can adversely affect the pregnancy outcome. Preliminary human data suggest a beneficial effect of prenatal zinc supplementation trials in particular on infant's neurobehavioral development. In the light of the currently available information, zinc supplementation at therapeutic load (30 mg/day) as it is proposed for the treatment of hormonal skin disorders to adolescents, cannot be toxic.

 

Singh M.

Essential fatty acids, DHA and human brain.

Indian J Pediatr. 2005 Mar; 72(3): 239-42.

Child Care and Dental Health Center, Arun Vihar, Noida, UP, India. This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Essential fatty acids cannot be synthesized in the body but they are required for maintenance of optimal health. There are two classes of polyunsaturated fatty acids (PUFAs)--omega-6 and omega-3. The parent omega-6 fatty acid, linoleic acid (LA) is desaturated in the body to form arachidonic acid while parent omega-3 fatty acid alpha-linolenic acid (ALA) is desaturated by microsomal enzyme system through a series of metabolic steps to form eicosapentaenoic acid (EPA) and decosahexaenoic acid (DHA). But there is a limited metabolic capability during early life to metabolize PUFAs to more active long-chain fatty acids. There is a critical role of EFAs and their metabolic products for maintenance of structural and functional integrity of central nervous system and retina. Most of the brain growth is completed by 5-6 years of age. At birth brain weight is 70% of an adult, 15% brain growth occurs during infancy and remaining brain growth is completed during preschool years. DHA is the predominant structural fatty acid in the central nervous system and retina and its availability is crucial for brain development. It is recommended that the pregnant and nursing woman should take at least 2.6 g of omega-3 fatty acids and 100-300 mg of DHA daily to look after the needs of her fetus and suckling infant. The follow-up studies have shown that infants of mothers supplemented with EFAs and DHA had higher mental processing scores, psychomotor development, eye-hand coordination and stereo acuity at 4 years of age. Intake of EFAs and DHA during preschool years may also have a beneficial role in the prevention of attention deficit hyperactivity disorder (ADHD) and enhancing learning capability and academic performance.

 

Ashworth CJ, Antipatis C.

Micronutrient programming of development throughout gestation.

Reproduction. 2001 Oct; 122(4): 527-35.

Scottish Agricultural College, Craibstone Estate, Bucksburn, Aberdeen AB21 9SB, UK. This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Vitamins and minerals serve essential roles in cellular metabolism, maintenance and growth throughout life. They are also central components of many enzymes and transcription factors. However, the need for optimum amounts of key micronutrients at critical stages during the periovulatory period and subsequent embryonic and fetal life has become the focus of sustained research activity only recently. In addition to folic acid, the minerals zinc, iron and copper and the antioxidant vitamins A and E are of particular importance during pregnancy. Both excesses and deficiencies of these micronutrients can have profound and sometimes persistent effects on many fetal tissues and organs in the absence of clinical signs of deficiency in the mother. The consequences of micronutrient imbalance on the developing conceptus may not be apparent at the time of the nutritional insult, but may be manifest later in development. However, supplementary micronutrients provided later in gestation or during postnatal life cannot completely reverse the detrimental effects of earlier micronutrient imbalance. Importantly, deficiency of a specific micronutrient, such as zinc, during pregnancy can result in a greater incidence of fetal malformation and resorptions than general under-nutrition. Given the range of micronutrients that affect development, the number of developmental stages susceptible to inappropriate micronutrient status and the diverse biochemical systems and types of tissue affected, it is challenging to propose a unifying hypothesis that could explain the effects of micronutrient imbalance on programming throughout gestation. Micronutrient imbalance can affect pregnancy outcome through alterations in maternal and conceptus metabolism, as a consequence of their essential role in enzymes and transcription factors and through their involvement in signal transduction pathways that regulate development. Micronutrient-induced disturbances in the balance between the generation of free oxygen radicals and the production of antioxidants that scavenge free radicals may provide an additional mechanistic explanation. The detrimental effects of many micronutrient deficiencies, particularly zinc and copper, can be alleviated by supplementary antioxidants, whereas deficiencies of antioxidant vitamins A and E are likely to reduce defense against free radical damage.

 

Szostak-Wegierek D.

[Importance of proper nutrition before and during pregnancy]

Med Wieku Rozwoj. 2000; 4(3 Suppl 1): 77-88.

Zaklad Zywienia Klinicznego, Instytut Zywnosci i Zywienia, ul. Powsinska 61/63, 02-903 Warszawa, Polska. This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Maternal nutrition before and during pregnancy may influence the course of the pregnancy, foetal development and the child's health in its early and also adult life. Maternal underweight before pregnancy (BMI<19.8 kg/m2) and low pregnancy weight gain may increase the risk of low infant birth weight. There is accumulating evidence that persons who were born with low body mass are more susceptible to insulin-independent diabetes, arterial hypertension, hypercholesterolemia and ischaemic heart disease, than those whose birth weight was normal. Recommendations concerning pregnancy weight gain are discussed. Folic acid deficiency during the peri-conceptional period may cause neural tube defects in the offspring. Full cover of folic acid requirement is necessary. This may be achieved only by diet supplementation or food fortification. Recommendations concerning folic acid supplementation during the peri-conceptional period are discussed. Folic acid deficiency during pregnancy may also contribute to the preterm delivery and low infant birth weight. The importance of antioxidant vitamins in the prevention of pregnancy hypertension and the consequences of vitamin A overdosage are discussed. Protective calcium activity against pregnancy hypertension and preterm delivery, the importance of maternal iron supplementation in the prevention of low infant birth weight, and also the problem of maternal zinc deficiency which increases the risk of the low infant birth weight, preterm delivery, malformations, post-term delivery and pregnancy hypertension were discussed as well as the consequences of deficiency of the iodine and n-3 fatty acids in the diet.

 

 

Vitamins and minerals, referred to collectively as micronutrients, have important influences on the health of pregnant women and the growing fetus. Iron deficiency results in anemia which may increase the risk of death from hemorrhage during delivery, but its effects on fetal development and birth outcomes is still unclear. Folic acid deficiency can lead to hematological consequences, pregnancy complications and congenital malformations, but again the association with other birth outcomes is equivocal. Zinc deficiency has been associated in some, but not all studies with complications of pregnancy and delivery, as well as with growth retardation, congenital abnormalities and retarded neurobehavioral and immunological development in the fetus. Iodine deficiency during pregnancy results in cretinism and possible fetal wastage and preterm delivery. Deficiency of other minerals such as magnesium, selenium, copper, and calcium have also been associated with complications of pregnancy, childbirth or fetal development. Deficiencies of vitamins other than folate may likewise be related to such complications; and vitamin A or beta-carotene supplements in pregnancy reduced maternal mortality by 50 % in a controlled trial in Nepal. Additional research is need on the prevalence of such deficiencies and their consequences and on cost-effective public health interventions for their control.

 
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