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Far too expensive to have FDA approve vitamin D – Dec 2013

I got interested in FDA approval as a result of FDA approval for a medical appliance in Dec 2013(Migraines).
The cost for getting a medical appliance approved seems to be about $20,000

So, I looked into creating a NDA (New Drug Application) for the FDA
I was hoping that if the FDA would approve it for treatment of one disease that doctors might use it off-lable for other diseases as well

$800,000 = average cost for NDA for a drug which has already gone thru 3 phases of trials, and has had at least one successful RCT

AND the average NDA length is 100,000 pages

FAR FAR too expensive and time consuming

Henry Lahore, admin of VitaminDWiki
Will continue to explore other avenues, such as cost savings to HMOs and employers
Please email (report @ the bottom of this page) if your country has a reasonable cost for new drug approvals.

By the way: as of Dec 2013 there were 36 Random Controlled clinical trials showning that Vitamin D works

Vitamin D prevents or treats 88 health problems
Surf to   is.gd/proofvitd   for updates or details
Select pink box in the upper right to select a language
Click on underlined items for details

Dec 2016 PDFs of this page (with 75 proofs) in
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Health Problem Treat
Prevent
Reduction by Vit DRCT = Randomized Controlled Trial
   * = link to additional RCT
CT = Clinical Trial
HypertensionT
P
149 to 142 mm Hg
HT risk reduced 10X
RCT*  *, 2400 IU.  100,000 IU*
When Vitamin D > 40 ng
Cardiovascular after attack T 32 % fewer deaths CT 1000 IU
Diabetes Type 1 P 85 % 12,000 kids, 2000 IU
Diabetes Type 2T 62 % RCT* CRP reduction, 4000 IU
Injection is far better - RCT *
RCT 50,000 IU/2weeks + probiotics
RCT 5,000 IU daily 6 months
Back Pain T 95 %
reduced 50%
5000/10000 IU
60,000 IU weekly
Influenza P 90 % RCT *, 2000 IU
Falls P 50%RCT, 100,000 IU monthly
RCT with Meals on Wheels 2016
Hip Fractures P 30 % RCT * 800 IU
Rickets P 98 % Turkey, 400 IU
NOT RCT, given to all children
Raynaud's Syndrome T 40 % RCT, visual scale, 20000 IU Avg
Menstrual pain P 76 % RCT, 7000 IU Avg,
70% reduction 2018
PMS reduced by half
Pregnancy risks P 50 % RCT, 4000 IU
C-section, unplanned P 50 % RCT, 4000 IU, small study
Low birth weight P 60 % RCT * 1000 IU of D2
TBP 60 % RCT, 800 IU
Breast Cancer P 60 % RCT, 1100 IU (2007)
Rheumatoid Arthritis pain T 40 % RCT, 500 IU, added to prescription
Cystic Fibrosis T 75 %
2nd study improved
RCT, pilot 4X fewer deaths 250,000 IU
RCT, pilot 8,200 IU
Chronic Kidney T 90 to 70 PTH RCT, 3500 IU,
Respiratory Tract Infection P 63 % 3 RCT, 4000 IU 1 year 2nd 2000/800 IU
20,000 IU weekly
Lupus T
T
zero flares
Pain reduced
Loading then 100,000 IU monthly,
RCT too
RCT 4,000 IU
Sickle Cell T Less pain
RCT, up to 100,000 IU/week
Leg ulcer healing T 4X faster RCT, 50,0000 IU/week, small study
Traumatic Brain Injury T 2X RCT, 20,0000 IU/day with progesterone
Parkinson's DiseaseT StabilizedRCT, 1200 IU/day
Multiple SclerosisP
T
68%
95% were CURED
RCT, 7100 IU prevent pre-MS ==> MS
20,000 to 140,000 IU/day
Congestive Heart Failure T 90 % RCT, 1000 IU infants (also: Adults, not RCT)
Middle Ear Infection P 30 % RCT, 1000 IU infants
GingivitisT 88 %RCT, 2000 IU
Muscle in seniors T 17 % more muscle RCT, 4000 IU
Antibiotic use when >70y T 47 % RCT, 60,000 IU monthly
Infants tallerBenefit1 cm tall RCT, 50,000 IU weekly,
for 8 weeks while pregnant
Gestational Diabetes T Reduced 3X RCT, 2 doses of 50,000 IU
After Heart Attack T +6% ejection fraction RCT, 800,000 IU one time
Prostate Cancer T Fewer +cores RCT, 4000 IU (2012)
Asthma P   T Reduced symptoms RCT, 60K IU/month;
RCT 50K IU/week
Need good D at 4 weeks into preg.
Depression T Reduced RCT 300,000 IU injection
RCT 1500 IU helped Prozac
RCT50,000 IU weekly
Low vitamin D
while breastfed
P All infants > 20 mg RCT, 5,000 IU
Fibromyalgia T Half of many still has FibroRCT, 30-48 ng
RCT 50K IU/week
Hives, Chronic T Reduced 40% RCT, 4000 IU added
CholesterolT Reduced 4 mg RCT, 400 IU + Ca
Weight Loss T lost 5 more lbs RCT, 2000 IU +diet +exercise
Gestational DiabetesP 40% RCT * , 5,000 IU
Chronic Obstructive
Pulmonary Disease
T 17X improvement CT, 50,000 IU weekly
RCT 100,000 IU monthly
Asthma T 1/2 Asthma attacks RCT >42 mg of vitamin D
Quality of Life (QoL) T Nursing Home QoL CT, 4,000 IU in daily bread
Death of Critically Ill
Patients
T 20% increase in survivability RCT 540 K IU loading than 90K monthly
Restless Leg Syndrome T Score 26 ==> 10 CT, Vitamin D dose size
not stated in abstract
Hepatitis-C T Aided normal drugs RCT 2.000 IU
Crohn's disease T improved when > 30 ng
2nd study fewer relapses
RCT 2,000 IU
10,000 IU RCT
Pre-term birth P 2.5X decrease, also: fewer
c-section & better Apgar
RCT 2,000 IU India
Cluster headaches T CH eliminated in 60% 10,000 IU, Mg, Omega-3, etc
Autism T 80% improved CT 300 IU/kg/day for 3 months
PreDiabetes T ~20% reduced RCT 60,000 IU/month
Weight loss:
Overweight and Obese
T 12 lbs in 6 months RCT 100,000 IU/month
Sarcopenia = muscle loss T 27% increase RCT 1,000 IU
Growing Pains T 60% decrease ~100,000 IU/month -NOT RCT
2nd study, similar results
Osteoarthritis pain T 60% decrease 50,000 IU/weekly - NOT RCT
ALS T helped 2,000 IU - NOT RCT, given to all
Vertigo T 3X reduction if raised > 10ng 600,000 IU load, then maint.
NOT RCT, given to all
Warts T 80% eliminated injection NOT RCT
60,000 IU/injection
Metabolic Syndrome P reduced 44% when VitD
increased by 30 ng
NOT RCT, given to all
Hay fever P reduced 48% RCT   1,000 IU for 30 days
Preeclampsia P Recurrance cut in half
3 RCT 3.6 X less likely if > 30 ng
50,000 IU every 2 weeks
4,000 IU daily
Blood cell cancer
Multiple Myeloma
T Survival 90% vs 50%10,000 IU/week
NOT RCT, given to all
Irritable Bowel Syndrome T Reduced3,000 IU spray RCT
Urinary Tract Infection P 50% reduction RCT 20,000 IU weekly
Mite Allergy P 5X reductionRCT 2,000 IU preg, 800 IU child
Perinatal depression
(depression near birth)
T 50% reduction RCT 2,000 IU for just a few weeks
Vaginosis T 10X reductionRCT 2,000 IU
Eczema T Reduced2 RCT 1,600 IU
Non-Alcoholic
Fatty Liver Disease
T Reduced RCT 20,000 IU weekly
Knee Osteoartiritis T Pain Reduced RCT 60,000 IU monthly after loading dose
Tuberculosis T Faster Recovery RCT single 450,000 IU dose
Stroke - Ischemic T Faster Recovery RCT single 600,000 IU injection
RCT single 300,000 IU injection
Sepsis T Reduce ICU and Hospital
length of stay by 7 days each
RCT 400,000 IU
Trauma deaths T 50% fewer deaths Vitamin D & Glutamine
NOT RCT, given to all
Hemodialysis patients T helped 50,000 IU weekly NOT RCT, given to all
Fatty liver - child T 2 X reduction RCT  Vitamin D & DHA
Fatigue T Reduced 100,000 IU single dose
NOT RCT, given to all
Sleep Disorders T Nicely treated RCT  50.000 IU bi-weekly
Pneumonia
(Ventilator-associated)
T RCT   Death rate cut in half300,000 IU injection
Infertile males T birth rate doubled RCT   300,000 IU + maint
Waist size T Waist size reduced 3 cm 100,000 IU loading + maint for 6 months
for those with Metabolic Syndrome
NOT RCT, given to all
Attention Deficient
Hyperactivity Disorder
T Reduced RCT  3,000 IU for 12 weeks
Alcoholic liver cirrhosis T improved survival1,000 IU of vitamin D NOT RCT
Diabetic nephropathy T Reduced HOMA-IR, FRS RCT 50,000 IU weekly
Ulcerative Colitis T Reduced 60% RCT 50,000 IU nano daily for a week
Obese weight loss T Lost 3X more pounds $10 of Vitamin D added to
  calorie restriction & walking

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