Wednesday, July 9, 2014

The growing cholecalciferol (Vit. D3) market

Lanolin, obtained as a bye product of sheep shearing, is a raw material for Vit. D3 manufacture.  Please see this link (click here) for an interesting insight!


* Muscle pains, back pains and general tiredness without any specific reason?  Could be Vit. D3 deficiency!

Do you know!?!

* 50% of the global population suffers Vit. D3 deficiency!

* 80% of the Indian population suffers Vit. D3 deficiency!

Vit. D3, the fat soluble vitamin is more than a metabolic participant, Vit. D3 has hormone-like behaviour in the body.  Vit. D3 is born from cholesterol (an interesting steroid molecule with vital body functions), please see the graphic below (!):

Sources of Vit. D3

Vit. D3 is chiefly synthesized in human skin (and skin of vertebrates) by using UVB rays of sunlight (a photochemical reaction occuring in the epidermis of skin).  Vit. D3 in small amounts is also available in foods: milk, liver, dairy products, eggs, fish, cod liver oil and some plants.  Certain lichen produce Vit. D3 (vegetarian source).

Vit. D3 is commercially synthesized by four companies in the world:

a)      Fermenta Biotech, Mumbai
b)      Dishman Pharmaceuticals, Ahmedabad (their plant is in Netherlands)
c)      DSM (Netherlands company)
d)     Zheijiang Garden (China)

Cholesterol is extracted from wool lanolin/wool alcohols left behind when sheep are sheared.  The cholesterol obtained from wool lanolin, is chemically converted to 7 dehydro cholesterol through a 4 step process.  The 7 dehydro cholesterol is then irradiated with UVB rays and purified to obtain a resin-like substance (Vit. D3). 

Irradiation of milk/organic foods also causes Vit. D3 production in the irradiated substance.

1 IU Vit. D3  = 0.025 microgram
100 IU = 2.50 microgram

Doctors recommend: 60000 IU/week for 4 to 8 weeks, followed by 1 sachet/chewable tablet (each of 60,000 IU) one per week. This is particularly for diabetics.

Recommended upper tolerable limit of Vit. D3 (9 years to 71 years plus, including pregnancy and lactation): 4000 IU/day.

RDA: 400 IU to 600 IU (as per age and patient status).  In elderly it is 800 IU.

Market picture in India

Vit. D3 market is rocking The May 2014 MAT (moving annual total) value is Rs. 252 crores (Rs. 2520 million) and has registered 40.8% growth in comparison to May 2013 MAT value (which was Rs. 179 crores market; MAT MAY 2013).

Vit. D3 is marketed as chewable tablets (biggest segment and fastest growing dosage type) (Rs. 87 crores May 2014 MAT value), capsules (mainly soft gelatin capsules) and sachets (powder).  All contain 60,000 IU/unit.

Uprise D3 (Alkem group), Tayo (Eris) and D3 Must (Mankind) are the top three brands in descending order (with MAT May 2014 values of Rs. 22 crores, Rs. 16 crores and Rs. 6.00 crores respectively). 

Vit. D3 is used in animal feeds, dietary supplements, drugs and for fortification of foods (like milk and other dairy products, milk mix beverage powders etc).

Global 2011 annual market estimate of Vit. D3 is USD: 400 million (40 crores USD or approx. Rs. 2400 crores per annum).

Vitamin D3 has an interesting profile.  This fat soluble vitamin is synthesized through a photochemical reaction in the human skin, and then undergoes interesting chemical changes in the body that are summarized in the below graphic:

In the above graphic, we see how cholesterol is converted to 7 dehydro cholesterol, effect of sunlight that provides UVB radiation converts this cholesterol to previtamin D3, which spontaneously isomerises to cholecalciferol.

The Vit. D3 thus formed is equally broken down fast!  Manufacture of Vit. D3 is a continuous process... but the moot point is DO WE GET ENOUGH SUNLIGHT - atleast 30 minutes a day?!  The answer is NO, for most of us!

Hydroxylation plays an important role for further conversions.  The first hydroxylation in liver by 25 hydroxylase converts cholecalciferol to calcidiol.  The kidneys then convert calcidiol that enters it through blood - to calcitriol. This is the second hydroxylation, where calcidiol (25 hydroxy cholecalciferol) is converted to calcitriol (1,25 di hydroxy cholecalciferol).

The conversion of calcidiol to the active form of Vit. D3: CALCITRIOL is as follows:

Calcitriol is a hormone like substance (chemical messenger): it binds to plasma VDBP (Vitamin D Binding Protein) and circulates in blood.  Calcitriol binds with VDRs (Vitamin D Receptors) that are present in a wide variety of tissues from head to toe, to exert beneficial actions!

Vitamin D3 (through mainly its active metabolite: calcitriol in blood) has important benefits:

1)      Improves intestinal absorption of calcium, zinc, magnesium, iron and phosphate (absorption is mainly in duodenum and jejunum)
2)      Regulates level of calcium and phosphate in blood (along with parathyroid hormone)
3)   Required for bone mineralization (influences osteoblast (cells that help form bone tissue) activity) and normal BMD (bone mineral density)
4)    Required for bone remodeling (also influences osteoclast (cells that cause resorption or removal of calcium from bone) activity)
5)    Vit. D3 stimulates immunity: especially binds with Vit. D3 receptors of monocytes, T cells, and macrophages.  Causes production of CANTHELICIDIN from monocytes, an antimicrobial substance.  This antimicrobial chemical has activity against Mycobacterium tuberculosis
6)      Helps in insulin production and insulin sensitivity at peripheral tissues
7)      Strengthens immunity: helpful in influenza & bacterial vaginosis, useful for monocyte – T cell – B cell functions, and for diabetics/other patients who suffer low immunity (body’s resistance to disease)
8)      Required for bone mineralization in aged, diabetics, postmenopausal women and other target groups: helps reduce falls in elderly
9)      Useful in cancer management: Helps reduce inflammation, has antiangiogenic activity (does not promote extra growth of blood vessels that encourages tumour growth), and decreases cell multiplication (tumour growth)
10)  Supports management of autoimmune diseases: multiple sclerosis, diabetes…
11)  Supports management of Parkinson’s disease
12)  Useful in management of osteomalacia (softening of bones in adults), osteoporosis (increased porosity and fragility of bones, leading to brittle bones) and rickets (weak bones and reduced growth of cartilage in children, leading to decreased height gain, bow legs and susceptibility to fractures): Vit. D3 is required for adequate mineralization of bones
13)  Helpful in fracture healing
14)  Supports management of depression
15)  Useful in heart disease, stroke management and hypertension management (Framingham Heart Study has also supported the benefit of normal Vit. D blood levels: >30 ng/ml)
16)  Pelvic floor abnormality results in urinary and fecal incontinence – it is also linked to low BMD etc: Vit. D3 helps in alleviation of these problems in the aged
17)  Beneficial and supportive for cognition (thinking) and retarding macular degeneration (in eye)
18)  Deficiency causes periodontal disease…
19)  Helps maintain levels of certain important enzymes like nitric oxide synthase, glutathione etc
20)  Supports pregnancy health
21)  Required for nerve function, vasodilation, hormonal activity and neuromuscular junction activity

Vit. D3 is a secosteroid with hormone like activity – regulates over 200 genes in the body

Lack of adequate exposure to sunlight on daily basis is a crucial reason for VDD (Vitamin D Deficiency) (Hypovitaminosis D) or Vit. D3 insufficiency/deficiency in modern life.

Normal levels of Vit. D3

Vit. D3 levels are measured as serum circulating 25 hydroxy cholecalciferol (calcidiol) levels: normal level is minimum: 30 ng/ml (cut-off value) (max. up to 74 ng/ml)

Hypovitaminosis D (VDD: Vitamin D Deficiency)

Vit. D3 insufficiency: 25 hydroxy cholecalciferol (calcidiol) levels: 20 to 29 ng/ml

Vit. D3 deficiency: 25 hydroxy cholecalciferol (calcidiol) levels: less than or equal to 20 ng/ml

VDD is defined as serum (blood plasma) 25 hydroxy cholecalciferol levels below 20 ng/ml.

Target groups of people susceptible to VDD

a)      Incidence of VDD is more in obese
b)      Elderly and those with inadequate exposure to sunlight
c)      Malnutritioned individuals
d)     Breastfed infants and mothers
e)      Diabetics/prediabetics (IGT)
f)       People with fat malabsorption
g)      Patients who have undergone gastric bypass or bariatric surgery
h)      People with dark skin
i)        Patients on anticonvulsants, glucocorticoids, antifungals and anti-AIDS medications
If most of your life is in the "shade" of buildings, vehicles, and offices or homes - it is time to get your 25 hydroxy cholecalciferol blood level tested!  Discuss the above insight on cholecalciferol with your doctor or healthcare provider or well-wishers... it will help you!  WISH YOU GOOD HEALTH!!

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