Information for Physicians

PHYSICIAN INFORMATION

CAPI Protocol Nutrient List

Protocol I (Adults 18+): Please Note – Nutrients Highlighted in Red have been shown to have an influence on asthma, or asthma related conditions/symptoms

• An essential fatty acid blend comprised of:

  • CERTIFIED ORGANIC OIL BLEND (FLAX SEED OIL, SUNFLOWER SEED OIL, PUMPKIN SEED OIL, EXTRA-VIRGIN OLIVE OIL)

  • RICE BRAN OIL EXTRACT

  • ROSEMARY EXTRACT

  • D-ALPHA TOCOPHEROL, 

  • MIXED TOCOPHEROLS, 

  • CURCUMIN EXTRACT.

• A bioflavonoid complex, up to a maximum additional 3tablets/3times daily, comprised of:

  • VITAMIN C (AS CALCIUM, POTASSIUM, MAGNESIUM AND ZINC ASCORBATES), 

  • GRAPE SEED EXTRACT,

  • ASCORBYL PALMITATE.  

• A multi-mineral complex

  • CALCIUM (CITRATE & CARBONATE)

  • MAGNESIUM 

  • ZINC 

  • IODINE 

  • COPPER 

  • MANGANESE 

  • CHROMIUM 

  • SELENIUM 

  • MOLYBDENUM (US AND CANADA ONLY)

  • SILICON (US ONLY)

  • VANADIUM (US ONLY)

  • ULTRA TRACE MINERALS

  • MARINE ORGANIC MINERALS (CANADA, NEW ZEALAND, AUSTRALIA, UNITED KINGDOM) 

• A multi-antioxidant/vitamin complex

  • BETA CAROTENE(PROVITAMIN A)

  • VITAMIN C (CALCIUM, POTASSIUM, MAGNESIUM AND ZINC ASCORBATES)

  • VITAMIN D3 (CHOLECALCIFEROL)

  • VITAMIN E (d-ALPHA TOCOPHERYL SUCCINATE)

  • VITAMIN B1 (THIAMINE HYDROCHLORIDE)

  • VITAMIN B2 (RIBOFLAVIN)

  • NIACIN

  • NIACINAMIDE

  • PANTOTHENIC ACID (CALCIUM d-PANTOTHENATE)

  • VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE)

  • VITAMIN B12 (CYANOCOBALAMIN)

  • FOLIC ACID

  • BIOTIN

  • COENZYME Q10 (NZ & AU SEE BELOW)

  • CHOLINE (BITARTRATE)

  • INOSITOL

IN US AND CANADA -

• BIOFLAVONOID COMPLEX (RUTIN, QUERCETIN, HESPERIDIN (35%)) (CITRUS SPP. L.)(FRUIT),  GREEN TEA EXTRACT (DECAFFEINATED) (CAMELLIA SINENSIS HUNT)(LEAVES), BILBERRY EXTRACT (VACCINIUM MYRTILLUS L.)(FRUIT) 

• CRUCIFEROUS EXTRACT (Brassica oleracea L.)(shoot) (CANADA, NEW ZEALAND, AUSTRALIA, UNITED KINGDOM)

• CURCUMIN EXTRACT (US ONLY)

• N-ACETYL L-CYSTEINE

• BROMELAIN

• ALPHA LIPOIC ACID

• OLIVE FRUIT EXTRACT

• BROCCOLI CONCENTRATE (0.04% SULFORAPHANE) (BRASSICA OLERACEA V. BOTRYTIS L.)(FLOWER)

• MIXED CAROTENOIDS (LUTEIN AND ZEAXANTHIN) 

INCLUDED IN NEW ZEALAND AND AUSTRALIA

• CYSTBINE HYDROCHLORIDE

• BROMELAIN

• PHYTOMENADIONE (VITAMIN K)

• BIOFLAVONOID COMPLEX

  • RUTIN

  • CITRUS BIOFLAVONOIDS

  • GREEN TEA (CAMELLIA SINENSIS) EXTRACT - EQUIV DRY LEAF

  • BILBERRY (VACCINIUM MYRTILLUS) EXTRACT - EQUIV FRESH FRUIT

• TURMERIC (CURCUMA LONGA) EXTRACT – EQUIV DRY ROOT

• MARIGOLD (TAGETES ERECTA) EXTRACT- EQUIV DRY FLOWER, EQUIV XANTHOPHYLL

• TOMATO (SOLANUM LYCOPERSICUM) – EQUIV DREY FRUIT, EQUIV LYCOPENE

• BROCCOLI (BRASSERICA OLERACEA) FLOWER POWDER

• UBIDECARENONE (COENZYME Q-10)

• ALPHA LIPOIC ACID

Determination of Protocol Manufacturer/Supplier

The RAINS 2007 Study Nutritional Protocols are comprised of a wide range of nutritional supplements. 

In any study involving nutritional supplements, it is critical to use standardized, pharmaceutical-grade products to ensure accuracy of results. 

CAPI searched for the highest-quality supplements available, with a synergistic blend, scientifically formulated and available internationally.

What do Nutritional Experts Recommend?

In conjunction with our research of the current medical literature on nutritional supplements and asthma, we examined the nutritional recommendations of the following seven leading, internationally recognized, nutritional authorities:

• Phyllis Balch, CNC;

• Dr. Michael Colgan, Ph.D.;

• Dr. Earl Mindell, Ph.D.;

• Dr. Michael Murray, N.D.;

• Dr. Richard Passwater, Ph.D.;

• Dr. Ray Strand, M.D.; and

• Dr. Julian Whitaker, M.D. 

Each of these professionals is recognized and respected within the scientific, medical or naturopathic communities. Each has published one or more works relating to nutrition.

Their recommendations were assessed and compiled in a study, by Lyle McWilliam, BSc, MSc.  Qualifying multiples were assessed quantitatively using fourteen criteria -- completeness; potency; bioavailability; bioactivity of vitamin E; cardiac health triad; homocysteine reduction triad; bone health complex; antioxidant triad; glutathione support; metabolic support; bioflavonoid profile; phenolic compound profile; lipotropic factors; and potential toxicities.

He then rated each of the 500+ products on a ten point scale, expressed as a decimal value with a maximum of 1.00. This was done using a sophisticated, selection criteria. 

1. The top ranked product rated a score of .9 .

2. Tied for second place were two products at .75

3. Tied for third place were two products at .70

4. Tied for fourth place were three products at .65

5. Tied for fifth place were six products at .60

The clear superior and top ranking company was also the final selection for the RAINS 2007 Study Protocols. 

Biographies

Phyllis A. Balch, CNC, is one of the health industry's leading voices. Ms. Balch is a coauthor of the bestselling Prescription for Nutritional Healing, as well as of Prescription for Nutritional Healing: The A-to-Z Guide to Supplements, and Prescription for Herbal Healing.

Dr. Michael Colgan, PhD, CCN, is an internationally recognized authority on sports nutrition. He was a senior member of the Faculty of Science at the University of Auckland and a visiting Rhodes Scholar at Rockefeller University of New York. Dr. Colgan is the Director of the Colgan Institute of Nutritional Science, San Diego.

Earl Mindell, R.Ph., Ph.D. is a professor of nutrition at Pacific Western University. In addition to writing several hundred articles on the subject of alternative health, Dr. Mindell has written more than thirty books and booklets. Dr. Mindell received his pharmacy degree from North Dakota State University and his doctorate in nutrition from Pacific Western University.

Dr. Michael Murray, N.D. is one of the world's leading authorities on natural medicine. He is a member of the faculty of Bastyr University of Seattle and the author of several best-selling books on naturopathy and nutrition.

Dr. Richard Passwater is a biochemist widely recognized for his contributions to nutritional research. An acknowledged expert in free radical pathology and trace element research, he is currently Director of the Solgar Nutritional Research Centre in Berlin, Maryland.

Ray D. Strand, M. D. is a graduate of the University of Colorado Medical School in 1971. He finished his postgraduate education at Mercy Hospital in San Diego, California. He has been in private family practice for over 30 years and over the past 7 years has focused his practice on nutritional medicine.

Julian Whitaker, M.D., is the Founder and Director of The Whitaker Wellness Institute, Inc. in Newport Beach, California. In addition to several books, he is the author and publisher of Health & Healing—the nation's leading health newsletter, with a circulation of nearly 700,000. His numerous health related articles appear in such magazines as Prevention and Let's Live. Dr. Whitaker is also a member of the American Medical Association.

Lyle McWilliam, BSc., MSc. was trained as a biochemist and kinesiologist in the 1970's. His work was, at the time, on the cutting edge of research into the biological activity of antioxidants as free radical scavengers in heart cell membranes. Mr. McWilliam is a former Canadian Member of Parliament and Member of the Legislative Assembly for British Columbia. He is currently serving, at the behest of Canada's federal Minister of Health, on the Transition Team for the Office of Natural Health Products, to help create a new federal regulatory framework that ensures full access to safe, effective and high quality natural health products.

Other factors CAPI considered in choosing the Protocol Nutrients:

Protocol Minerals - Purity

A study of 70 brands of calcium supplements indicated that lead levels in only 2 of the 25 unrefined calcium carbonate products met federal safety guidelines. The average level of lead in calcium carbonate supplements was over 6 times the safety limit. 

Supplements from dolomite and bone meal were 4 and 11 times respectively over the limit.²²⁷

We needed to ensure a manufacturer could guarantee the purity of their products before we would consider them for our protocols.

Is Iron Necessary?

There is evidence that iron supplementation is not necessary for many people, and, in some cases can be detrimental to health by increasing free radical production in the body. 

Iron is a nutrient that should only be taken under physician's advice, after careful monitoring of iron levels. 

As such, we felt it was inappropriate to include iron as one of the protocol nutrients.

Vitamin A Toxicity?

Likewise, there is evidence to suggest vitamin A can be toxic at dosages greater than 10,000 IU. Beta carotene is a precursor to vitamin A. That means that the body converts beta carotene to vitamin A, as needed. This makes beta carotene a safe, effective method of obtaining vitamin A. We therefore decided we would use a supplement that used beta carotene instead of vitamin A. 

International Availability

As part of the strategy of the RAINS Study, we also wanted to reach the largest possible number of participants. We therefore wanted an international supplier, with products pre-approved for distribution in a number of countries around the world.

Additional Criteria Considered

In the end, we found only one manufacturer, who met all of the above criteria, in addition to the following:

• Pharmaceutical grade nutrient

• U.S. Pharmacopeia (USP) Good Manufacturing Process (GMP) drug approved facility. (GMP standards require documented proof of certain education, training, and hands-on experience for anyone involved in the manufacturing process.

• Independent laboratory testing of products

• Verifiable high bioavailability of nutrients

• Assurance of tablet disintegration including testing for hardness, thickness and uniform weight of tablets

• Synergistic balance and blend of nutrients based on cellular research

• Guaranteed potency and purity of products

• Standardized botanical extracts

• Wide spectrum of nutrients shown in studies to have influence in asthma

• Use of internet technology to assist in protocol education

• Impeccable credentials

• Solid reputation

• In house manufacturing

• Available direct shipping from manufacturer to participants

The founder of the chosen protocol nutrient manufacturing company is a world renowned microbiologist and immunologist, Dr. Myron Wentz, an internationally recognized pioneer in the development of human cell culture technology and infectious disease diagnosis.

In 1977, through one of the companies he founded, Gull Laboratories, Dr. Wentz developed the first commercially available tests for diagnosing Herpes and Epstein-Barr viruses. Gull Laboratories test kits are recognized and used in clinical laboratories and hospitals in over 50 countries.

In summary, the RAINS 2007 Study Protocol Nutrients were chosen based on six prime factors:

• The consolidated recommendations of Phyllis Balch, CNC; Dr. Michael Colgan, Ph.D.; Dr. Earl Mindell, Ph.D.; Dr. Michael Murray, N.D.; Dr. Richard Passwater, Ph.D.; Dr. Ray Strand, M.D.; and Dr. Julian Whitaker, M.D.

• CAPI's research into asthma and nutritional influence

• CAPI's Retrospective Survey of asthmatics

• Bioflavonoid effects on histamine, inflammation and oxidation

• Dose-dependant nature of bioflavonoids and ascorbic acid as mineral ascorbates

• Highest quality supplements available

Information on the Protocol Nutrients are listed in both the Compendium of Pharmaceuticals and Specialties (CPS), and, the Physician's Desk Reference (PDR)

The chosen protocol nutrients are also some of the very few listed nutritional supplements listed in the 2001-2007 Canadian CPS and the US PDR 1999-2007.

The CPS lists more than 3,000 drug names. The Main “white pages” listings are arranged alphabetically by brand name and are based on the product monographs prepared by pharmaceutical manufacturers and approved by the Therapeutic Products Programme (TPP), Health Canada. It also includes an illustrated product identification guide, a brand and generic name index, a manufacturers’ index, and “Information for the Patient” monographs on select drugs. Virtually every physician in the United States uses the Physicians' Desk Reference (PDR)--the most widely used compilation of prescribing information used by physicians. Readership studies indicate that nine out of ten doctors consider the PDR their most important and most frequently consulted reference book.

The PDR is an annual directory of ethical pharmaceutical, biological, and diagnostic products intended as a service to the medical field.

 Significance of the listings:

Physicians and health care professionals rely on the PDR as a source for understanding the many pharmaceutical and non-pharmaceutical products available. Physicians often recommend or prescribe a certain product or pharmaceutical based on the validity and reliability of the descriptions in the PDR.

Physicians depend on the fact that the manufactured product described in the PDR contains the exact amounts and types of ingredients listed and that the product delivers the precise effects described therein.

Each year, copies of the PDR are distributed to approximately a half-million practicing physicians and chief pharmacists at major hospitals in the United States. In addition, medically sophisticated consumers, institutions, and other allied health professionals--including dentists, nurses, veterinarians, hospitals, managed care organizations, and public and legal libraries--purchase the book, raising the total distribution to well over one million copies. The PDR includes prescribing information on over 3,500 products from more than 250 manufacturers.

Notes:

Background Scientific References for RAINS 2007 Study Available at http://www.asthmaworld.org/Citations.htm

Please direct any research inquiries to the CAPI Research Coordinator at  research@asthmaworld.org