Overview and Vitamins

How are dietary supplements defined by the FDA

An oral product that is intended to supplement the diet

what may be included in/as a dietary supplement?

vitamins, minerals, herbs, botanicals, amino acids, enzymes, and live microbials

what are the other names for dietary supplements?

nutraceuticals, natural products, supplements, herbs, botanicals, phytochemicals, components of complementary and alternative medicine (CAM)

what are the most popular single vitamin/mineral products?

vitamin D, vitamin C, and calcium

what are the most commonly used non-vitamin/mineral dietary supplements in ADULTS?

fish oil, glucosamine ± chondroitin, pre/probiotics, melatonin, and co-enzyme Q 10

what are the most commonly used non-vitamin/mineral dietary supplements in CHILDREN?

fish oil, melatonin, pre/probiotics, and echinacea

who commonly uses dietary supplements?

females, increased usage with age, those with college or higher degrees, white or Asian, western US (mountain and pacific states), higher socioeconomic status, physically active, non-cigarette smokers, kids with parents who use them, those that believe they will work, and those that receive care from CAM providers

what are some examples of CAM providers?

acupuncturists and chiropractors

why can dietary supplements be a problem?

~1/4 of people using them do not tell their providers and the manufacturers of dietary supplements do not need to adhere to strict potency and purity standards that are applied to Rx and non-Rx drugs

when are dietary supplements monitored for safety?

post-marketing

when can dietary supplements be removed from shelves?

only if a dietary supplement is proven to be unsafe

which laws/guidelines discuss dietary supplements?

DSHEA of 1994, cGMP 2007, and Dietary Supplement and Nonprescription Drug Consumer Protection Act 2006

what does the DSHEA of 1994 say about dietary supplements?

they are excluded from the strict purity/potency standards applied to other drugs, they only had to meet the standards that applied to food preparation, limited oversight of the manufacturing process, it is up to the manufacturer to ensure content/purity/consistency/prevent contamination etc., created a “buyer-beware market”

which law created a buyer-beware market?

DSHEA of 1994

what did cGMP guidelines published in 2007 say about dietary supplements?

they must be manufactured in a quality manner, without impurities, labeled correctly, and raw materials must be evaluated by the manufacturer.

what did the dietary supplement and nonprescription drug consumer protection act say about dietary supplements?

manufacturers, packers, or distributors of dietary supplements are required to submit to FDA reports of serious adverse events that are based on specific information received from the public

what are the names of the quality assurance programs for DS?

USP, ConsumerLab.com, and NSF

what does the USP do/say regarding DS

Sets rigorous standards for potency, purity, performance, and consistency

Products certified to contain the listed ingredients in the indicated amounts to be bioavailable and free of contaminants and manufactured in appropriate sanitary and controlled conditions.

Conducts yearly facility audits and surveillance of USP products on store shelves

what does ConsumerLab.com do in regards to DS?

Dietary supplements tested for identity, purity, and consistency - must pass random testing every 12 months

what does the NSF say/do regarding DS?

Certifies food, water, and DS quality. Confirms DS label ingredients and lack of contaminants, and screens dietary supplements for athlete use to ensure they do not contain the 270 banned substances/undeclared ingredients such as opioids, stimulants, and steroids.

when was the National Sanitation Foundation established?

1944

which program is an independent, nonprofit organization that standardized sanitation and food safety?

NSF

What are the important points regarding dietary supplements?

use for the shortest duration possible, inform medical provider before taking, purchase a product with a third-party seal, purchase from large reputable companies, continue to use the same DS formulation, and report any adverse events to a health care provider

what are vitamins and minerals?

things not needed for the majority of healthy patients who eat a well-balanced, nutritious diet (vitamins/minerals are better absorbed through food)

T/F: vitamins and minerals can be used as a substitute for a balanced diet

false

T/F: natural and synthetic forms of dietary supplements are equally efficacious

true

What is included in the Dietary Guidelines for Americans?

customize and enjoy nutrient dense foods/drinks, limit foods/drinks containing higher amounts of added sugars (<10% of calories), limit saturated fat (< 10% of calories), limit trans fats, sodium (<2300 mg daily), and limit alcohol

who developed the dietary reference intake (DRI)?

the Food and Nutrition Board at the National Academies of Sciences, Engineering, and Medicine

what is DRI

reference values for nutrients dependent on age and sex

what things are included in DRI

Recommended dietary allowance (RDA), adequate intake (AI), estimated average requirement (EAR), and tolerable upper intake level (UL)

what is RDA?

the average daily dietary intake sufficient to meet the nutrient requirements of ~98% of health subjects in a group - calculated from EAR

what is AI

believed to cover the needs of all healthy persons in the group but less data or uncertainty in the data

which vitamins are fat soluble?

A, D, E, and K

where do vitamins A, D, E, and K come from?

fat, oil, milk, and egg yolks

when do patients experience deficiencies in vitamins A, D, E, and K?

limited fat intake or fat absorption is affected

what leads to limited fat intake?

starvation, eating disorders, selective diets, bariatric surgery

what causes fat absorption to be affected?

small intestine pathologies (Crohn’s Disease, small intestine resection, cystic fibrosis, celiac disease, and bariatric surgery), orlistat, and cholestyramine

what are the two classes of vitamin A?

Retinoids and carotenoids

types of vitamin A retinoids:

retinol

types of vitamin A carotenoids

Pro-Vitamin A carotenoids (Alpha-carotene and beta-carotene) and non-pro-vitiamin A carotenoids (Lutein and Lycopene)

which carotenoids concert vitamin A in the small intestine

Pro-Vitamin A

what is vitamin As role?

it is an antioxidant, plays a role in growth, reproduction, skeletal and tooth development, functioning of most organs, synthesis of epithelial cell mucous secretions (mucosal barrier), and plays a key role in vision (conjunctiva, retina, cornea)

signs of vitamin A deficiency:

dry eyes and night blindness

which type of vitamin A is better for high doses and longer use?

beta-carotene

toxicity risk associated with beta-carotene?

limitations on absorption and conversion to retinol in vivo, could increase lung cancer risk and death in smokers and former smokers, and carotenodermia

toxicities associated with vitamin A:

fat soluble and stored in liver (can accumulate chronically with increased risk in pts with renal/liver impairment or pts on multiple forms of vitamin A containing products) and teratogenic (only use pre-natal MVI)

what are the signs and symptoms of liver toxicity due to vitamin K accumulation?

dry skin, painful muscles/joints, bone fractures, fatigue, depression, and abnormal LFTs

what are the different types of vitamin D?

Ergocalciferol (vitamin D2 and D3), Cholecalciferol (Vitamin D3), 25-hydroxyvitamin D3 (Calcidiol), 1,25-dihydroxyvitamin D3 (Calcitriol)

what is vitamin Ds role in the body?

bone and mineral homeostasis (involved with PTH, phosphate, and calcitonin to maintain serum calcium levels), and has been evaluated for CV and cancer prevention

who is at higher risk for vitamin D deficiencies?

those with inadequate sun exposure/dairy consumption, renal/liver disease, breastfed infants, older adults, and those on antiepileptics (phenytoin, carbamazepine)

what bone issues can be caused by vitamin D deficiency?

rickets and osteopenia/porosis

signs of vitamin D toxicity

anorexia and hypercalcemia (kidney stones, soft tissue calcification)

types of vitamin E:

Alpha tocopherol

role of vitamin E in the body

antioxidant, heme biosynthesis, steroid metabolism, collagen formation, and has been evaluated for many conditions (Alzheimer’s, Parkinson’s, cancer, etc.) but none have shown regular benefit

signs of vitamin E deficiency

peripheral neuropathy, muscle weakness, and hemolytic anemia

signs of vitamin E toxicity

bleeding, N/V, and weakness/fatigue

types of vitamin K:

phytonadione (K1) and menaquinone (K2)

what is phytonadione?

vitamin K1 that is used in vitamin K supplementation

what is menaquinone?

vitamin K2 that is a product of colonic bacterial metabolism that supplies a large amount of the body’s requirement

vitamin Ks role in the body

synthesis of clotting factors II, VII, IX, X, Proteins C and S, and activates osteocalcin

when is vitamin K often given

at birth to prevent hemorrhage and to reverse warfarin

who is at increased risk for vitamin K deficiency

those on broad spectrum antibiotic therapy

signs of vitamin K deficiency

bleeding, increased PT/INR

when is vitamin K toxicity clinically relevant

if the patient is on warfarin therapy

which vitamins are water soluble

vitamin C and B

which types of vitamins have a higher risk of toxicities

fat soluble

which types of vitamins are not stored in the body and excess quantities are excreted in the urine

water soluble

types of vitamin C

ascorbic acid

role of vitamin C

necessary to build precursors for collagen, bone, and tooth formation, and helps absorb iron from the blood

signs of vitamin C deficiency

Scurvy ArgGGGGG (weaking of collagen structures, defects in tooth formation, gingivitis, capillary hemorrhaging, and impaired wound healing)

signs of vitamin C toxicity

N/V, stomach cramps, diarrhea, and nephrolithiasis

types of vitamin B12

cyanocobalabimr

role of B12

active cell division (particularly in bone marrow, CNS, and GI tract cells), involved in fat, protein, and carb metabolism, and reduces homocysteine levels (elevated homocysteine sometimes associated with CV events)

who is at risk for B12 deficiencies

older adults, patients on acid suppressive therapy, vegetarians, and metformin users

where is B12 absorbed?

in the distal ileum after complexing with IF from the stomach

signs of B12 deficiency

pernicious anemia, neurological symptoms (gait disturbances, confusion, agitation, psychosis, hallucinations)

toxicities for B12

none

types of B9

folic acid (synthetic) and folate (naturally occurring from food)

role of vitamin B9

cell division, DNA production, brain/spinal cord development, and reduces homocysteine levels

which supplement should women of child-bearing age take to prevent neural tube defects

vitamin B9

who is at risk for B9 deficiencies

alcoholics and patients on methotrexate and anticonvulsants

which drugs are anticonvulsants?

carbamazepine, oxcarbamazepine, lacosamide, lamotrigine, phenytoin, divalproex, phenobarbital, topiramate, and levetiracetam

signs of B9 deficiencies

anemia, sore mouth, diarrhea, CNS effects (irritability, confusion), MTHFR polymorphisms

B9 toxicities

none

types of B3

Niacin and nicotinic acidr

role of b3

electron transfer agents that are essential for aerobic respiration of all cells - niacin is indicated for hyperlipidemia

common side effect of Niacin

flushing

what does niacin work on most in hyperlipidemia

TG and increases HDL

who is at risk for B3 deficiencies

alcoholics, malnourished, severe diet restrictions (large corn consumption)

Signs of B3 deficiencies

Pellagra

signs of Pellagra

dermatitis, diarrhea, dementia, glossitis, rash, GI tract effects, and bleeding

toxicities of B3

Gi symptoms (N/V/D), HTN, and hepatoxicity

types of B6

pyridoxine

role of B6

cofactor for many enzymes, helps with nausea and vomiting in pregnancy, and reduces homocysteine levels

who is at risk of B6 deficiencies

alcoholics, malabsorption, and medications such as isoniazid

signs of B6 deficiency

difficult to distinguish from Pellagra-like symptoms

toxicity of B6

severe neuropathy

types of B1

thiamine

role of B1

Krebs cycle and biochemical conversion cycles (heart, nerve cell function, carb metabolism)

who is at risk for B1 deficiencies

alcoholics, malnutrition/diet selectivity, malabsorption, and chronic diarrhea