Background
Methods
Participants
Enrollment criteria
Participants
Arizona | National Group | |||
---|---|---|---|---|
Placebo | Supplement | Placebo | Supplements | |
Total Participants
| 27 | 26 | 42 | 46 |
Male
| 22 (81%) | 25 (96%) | 39 (93%) | 39 (85%) |
Female
| 5 (19%) | 1 (4%) | 3 (7%) | 7 (15%) |
Age (years)
| 10.5 ± 3.1 | 9.3 ± 3.2 | 9.5 +/- 5.7 | 13.1 +/- 10.0 |
Diagnosis
| 74% Autism; 19% Aspergers; 7% PDD/NOS | 96% Autism; 4% Aspergers | 67% Autism 12% Asperger's 21% PDD/NOS | 85% Autism 7% Asperger's 9% PDD/NOS |
Medications
| 52% no medication; 8 (30%) psycho-pharmaceuticals - primarily risperdal and clonidine; 4 (15)% CNS stimulants (primarily Concerta); 1 (4%) anti-convulsants; 1 (4%) asthma/allergy medications; 1 (4%) GI medications; 1 (4%) Insulin medications; 2 (7%) blood pressure medications | 42% no medication; 8 (32%) psycho-pharmaceuticals - primarily risperdal and clonidine; 1 (4%) CNS stimulants (Dextrostat); 1 (4%) anti-convulsants; 3 (12%) asthma/allergy medications; 2 (8%) GI meds | 64% no medications; 10 (24%) atypical anti-psychotics (primarily Risperdal); 2 (5%) on CNS stimulants; 3 (7%) on anti-convulsants; 4 (10%) on allergy/asthma medications; 1 (2%) on GI medications | 52% no medications; 14 (30%) atypical anti-psychotics (primarily risperdal); 3 (7%) on CNS stimulants; 7 (15%) on anti-convulsants (primarily Depakote); 6 (13%) on allergy/asthma medications; 1 (2%) on muscle relaxants; 1 (2%) on anti-coagulants |
Special Diets
| 67% on regular diet; 3 gluten-free, casein-free diet; 2 reduced dairy; 2 low sugar | 88% on regular diet; 1 gluten-free; 1 reduced gluten; 1 reduced dairy | 76% on regular diet; 11% gluten-free, casein-free diet; 1 reduced gluten and casein diet; 2 milk-free; 1 soy-free 1 Feingold diet | 67% on regular diet; 11% gluten-free, casein-free diet; 15% reduced dairy/gluten/casein; 1 dairy-free; 1 casein-free; 1 gluten-free; 1 low sugar; 1 no red/blue dyes; 1 lactose free; 1 low soy; 1 vegetarian; 1 no eggs |
Nutritional Supplements
| None | 1 on fish oil; 3 on melatonin | 5% on fish oil; 1 on melatonin; 1 digestive enzymes; 1 on glucosamine & chondroitin sulfate; 1 on constipation relief | 4% on fish oil; 1 on glutamine; 1 on herbal sleep extract; 1 on multi-nutrient supplement |
Symptom | % with moderate or severe problem |
---|---|
bedwetting | 20% |
wets pants/diapers | 18% |
soils pants/diapers | 21% |
diarrhea | 14% |
constipation | 24% |
sleep problems | 36% |
eats too much/little | 48% |
limited diet | 47% |
hyperactive | 40% |
lethargic | 9% |
hits/injures self | 20% |
hits/injures others | 18% |
destructive | 20% |
sound sensitive | 43% |
anxious/fearful | 30% |
unhappy/crying | 12% |
seizures | 2% |
obsessive speech | 27% |
rigid routines | 36% |
shouts/screams | 38% |
demands sameness | 34% |
often agitated | 31% |
not sensitive to pain | 30% |
hooked or fixated on certain objects | 62% |
repetitive movements | 43% |
Study Protocol
Supplement/Placebo Formulation
Supplement
VITAMINS | Current Supplement (for 60 lb child) | RDA/AI (4-8 yr) (AI values indicated by asterisk) | Upper Limit for children ages 4-8 years |
---|---|---|---|
Vitamin A
(palmitate) | 1000 IU | 400 mcg (1333 IU) | 900 mcg (3000 IU) |
Vitamin C
(calcium ascorbate) | 600 mg | 25 mg | 650 mg |
Vitamin D3
(cholecalciferol) | 300 IU | 5 mcg (200 IU)* | 50 mcg (2000 IU) |
Vitamin E
| 150 IU | 7 mg (10.5 IU) | 300 mg (450 IU) |
Mixed Tocopherols
| 70 mg | n/a | n/a |
Vitamin K
| 0 | 55 mcg* | ND |
B1
(thiamin HCl) | 20 mg | 0.6 mg | ND |
B2
(riboflavin) | 20 mg | 0.6 mg | ND |
B3
(niacin/niacinamide)
| 15 mg niacin 10 mg niacinamide | 8 mg | 15 mg |
B5 (calcium d-pantothenate) | 15 mg | 3 mg* | ND |
B6 (pyridoxine HCl) | 40 mg | 0.6 | 40 mg |
B12 (cyanocobalamin) | 500 mcg | 1.2 mcg | ND |
Folic Acid
| 100 mcg | 200 mcg | 400 mcg |
Folinic Acid
| 550 mcg | ||
Biotin
(biotin) | 150 mcg | 12 mcg* | ND |
Choline
(choline chloride) | 250 mg | 250 mg* | 1000 mg |
Inositol
| 100 mg | n/a | n/a |
Mixed Carotenoids
| 3.6 mg | n/a | n/a |
Coenzyme Q10
| 50 mg | n/a | n/a |
N-acetyl cysteine
| 50 mg | n/a | n/a |
MINERALS
| |||
Calcium
(from calcium ascorbate) | 100 mg | 800 mg* | 2500 mg |
Chromium
(chromium amino acid chelate) | 70 mcg | 15 mcg* | ND |
Copper
| 0 | 440 mcg | 3000 mcg |
Iodine
(potassium iodide) | 100 mcg | 90 mcg | 300 mcg |
Iron
| 0 | 10 mg | 40 mg |
Lithium
(lithium orotate) | 500 mcg | n/a*** | n/a |
Magnesium
(magnesium chloride hexahydrate) | 100 mg | 130 mg | 110 mg** |
Manganese
(manganese amino acid chelate) | 3 mg | 1.5 mg* | 3 mg |
Molybdenum
(sodium molybdate dihydrate) | 150 mcg | 22 mcg | 600 mcg |
Phosphorus
| 0 | 500 mg | 3000 mg |
Potassium
(potassium chloride) | 50 mg | 3.8 g* | n/a |
Selenium
(selenomethionine and sodium selenite) | 22 mcg | 30 mcg | 150 mcg |
Sulfur
(MSM) | 500 mg | n/a | n/a |
Zinc
(zinc gluconate) | 12 mg | 5 mg | 12 mg |
Other Ingredients in Current Supplement | Natural cherry flavor; sucrose, sucralose; preservatives (potassium sorbate, sodium benzoate). |
Dosage
Lab Measurements
Assessing Autistic Symptoms and Severity
Statistical Analysis
Participant Withdrawals, Removals, and Adverse Effects
Results
Nuritional/Metabolic Results
Vitamins
Vitamins | Units | Neuro-typicals (n = 44) | Arizona Treatment Group (N = 18) | Arizona Placebo Group (N = 22) | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Pre | Post | % change | p-value | Pre | Post | % change | p-value | |||
Vit. A (plasma) | ug/100 ml | 54.9 +/- 12 | 62.3 +/- 12 | 59.0 +/-13 | -5% | n.s. | 50.2 +/- 7.2 | 52.9 +/-13 | +5% | n.s. |
Total Carotenes (beta carotene and other carotenes, in plasma) | ug/ 100 ml | 178 +/-53 | 158 +/- 53 | 170 +/- 65 | +7% | n.s. | 136 +/- 53 | 150 +/-59 | +10% | n.s. |
Vit B1 Thiamine (WB) | ug/l | 63 +/-9 |
63
+/- 12
|
80
+/-12
|
+27%
|
0.0005
| 65 +/-9 | 65 +/-11 | 0% | n.s. |
Vit B2 Riboflavin (WB) | ug/l | 282 +/-52 | 291 +/- 42 | 295 +/-36 | 1% | n.s. | 272 +/- 45 | 262 +/-55 | -3% | n.s. |
Vit B3 Niacin and Niacinamide (WB) | ug/l | 7.07 +/-1.0 |
6.7
+/- 1.1
|
7.3
+/-0.9
|
+9%
|
0.04
| 7.1 +/- 1.3 | 7.2 +/-1.0 | +1% | n.s. |
Vit B5 Pantothenic Acid (WB) | ug/l | 714 +/-180 | 654 +/- 104 | 748 +/-170 | +14% | 0.06 | 600 +/- 117 | 629 +/-159 | +5% | n.s. |
Vit B6 (as P5P in RBC) | ug/l | 15.2 +/-5.3 | 20.3 +/- 15 |
58.1
+/-24
|
+187%
|
0.00001
| 17.8 +/- 14 | 16.1 +/-11 | -10% | n.s. |
Folic Acid (serum) | ug/l | 18.7 +/-6.1 | 20.1 +/- 7.5 |
26.3
+/-7.1
|
+31%
|
0.03
| 15.3 +/- 4.8 | 17.8 +/-8.2 | 17% | 0.09 |
Vit B12 (plasma) | ng/l | 676 +/-215 |
696
+/- 231
|
835
+/-259
|
+20%
|
0.002
| 690 +/- 240 | 639 +/-246 | -7% | n.s. |
Vit C (plasma) | mg/ 100 ml | 1.33 +/-0.46 |
1.59
+/- 0.60
|
2.08
+/-0.34
|
+31%
|
0.007
| 1.60 +/- 0.59 | 1.55 +/-0.51 | -3% | n.s. |
Vit D3
(25-hydroxy in plasma) | ug/l | 28.6+/-8.5 | 29.6 +/- 8.3 |
25.4
+/-6.2
|
-14%
|
0.04
| 28.9 +/- 8.7 | 25.9 +/-7.8 | -10% | n.s. |
Total Vit E (serum) | mg/ 100 ml | 0.90 +/-0.32 |
0.78
+/- 0.16
|
0.97
+/-0.21
|
+24%
|
0.002
| 0.75 +/- 0.19 | 0.84 +/-0.24 | +12% | n.s. |
Biotin (WB) | ng/l | 491 +/-164 |
395
+/- 115
|
595
+/-225
|
+51%
|
0.008
|
377
+/- 88
|
527
+/-162
|
+40%
|
0.001
|
Vit K (plasma) | nmol/l | 295 +/- 189 | 288 +/- 116 | 330 +/- 165 | +15% | n.s. | 317 +/- 197 | 277 +/- 98 | -13% | n.s. |
Vitamin-like substances
| ||||||||||
Free Choline (RBC) | mg/l | 5.6 +/- 1.7 | 6.7 +/- 3.5 | 5.9 +/- 2.0 | -12% | n.s. | 6.4 +/- 2.3 | 7.0 +/- 1.7 | +10% | n.s. |
Total Choline (RBC) | mg/l | 310 +/- 51.4 | 363 +/- 59 | 343 +/- 43 | -5% | n.s. | 361 +/- 67 | 368 +/- 42 | +2% | n.s. |
Lipoic Acid (plasma) | ug/l | 2.9 +/- 1.2 | 3.1 +/- 1.8 | 2.3 +/- 0.7 | -22% | n.s. | 2.3 +/- 1.5 | 2.1 +/- 1.2 | -9% | n.s. |
Biomarkers of functional need for vitamins
| ||||||||||
FIGLU | ug/l | 1.62 +/- 0.72 |
1.87
+/- 0.93
|
1.32
+/- 0.64
|
-29%
|
0.01
| 2.11 +/- 0.91 | 1.85 +/- 0.98 | -12% | n.s. |
Methylmalonic Acid | mg/g-creat | 7.2 +/- 4.8 |
8.2
+/- 5.6
|
4.8
+/- 4.2
|
-41%
|
0.03
| 6.7 +/- 5.7 | 8.7 +/- 10.4 | +30% | n.s. |
N-methyl-nicotinamide | mg/g-creat | 3.44 +/- 2.1 | 4.62 +/- 3.5 | 3.1 +/- 1.6 | -33% | n.s. | 4.94 +/- 5.1 | 5.15 +/- 3.1 | +4% | n.s. |
Kryptopyrroles | ug/dl | 35.8 +/- 15 | 38.0 +/- 23 | 36.2 +/- 29 | -5% | n.s. | 40.3 +/- 29 | 38.1 +/- 24 | -5% | n.s. |
Treatment Group
Placebo Group
Essential Minerals
Essential Minerals + other minerals | Neuro-typicals (n = 44) | Treatment Group (n = 19) | Placebo Group (n = 20) | ||||||
---|---|---|---|---|---|---|---|---|---|
Pre | Post | % change | p-value | Pre | Post | % change | p-value | ||
Calcium-WB (mg/dL) | 5.8 +/- 0.3 | 5.9 +/- 0.4 | 6.0 +/0.4 | +1% | n.s. | 5.8 +/- 0.3 | 5.6 +/- 0.5 | -2% | n.s. |
Calcium-RBC (ug/g) | 22.4 +/- 6 |
19.2
+/- 7.9
|
27.4
+/- 3.6
|
+43%
|
0.001
|
19.5
+/- 7.5
|
25.2
+/- 4.3
|
+30%
|
0.02
|
Calcium-Serum (mg/dL) | 9.60 +/- 0.2 | 9.65 +/- 0.4 | 9.51 +/- 0.3 | -1% | 0.07 | 9.59 +/- 0.4 | 9.53 +/- 0.3 | 0% | n.s. |
Chromium-RBC (ng/g) | 0.80 +/- 0.4 | 1.02 +/- 0.50 | 0.81 +/- 0.6 | -21% | n.s. | 0.77 +/- 0.44 | 0.70 +/- 0.3 | -9% | n.s. |
Copper-WB (ug/dL) | 89 +/- 14 | 91.2 +/- 13 | 95.9 +/- 17 | +5% | 0.09 | 93.9 +/- 10 | 95.5 +/- 13 | +2% | n.s. |
Copper-RBC (ug/g) | 0.72 +/- 0.09 | 0.75 +/- 0.08 | 0.78 +/- 0.08 | +4% | 0.06 | 0.74 +/- 0.08 | 0.77 +/- 0.08 | +4% | n.s. |
Iodine-Urine (ug/mg creatinine) | 0.26 +/- 0.2 |
0.28
+/- 0.26
|
0.43
+/- 0.27
|
+54%
|
0.03*
| 0.23 +/- 0.15 | 0.22 +/- 0.15 | -5% | n.s. |
Iron-RBC (ug/g) | 833 +/- 64 |
887
+/- 101
|
806
+/- 54
|
-9%
|
0.006
|
883
+/- 80
|
826
+/- 51
|
-7%
|
0.02
|
Iron-Serum (ug/dL) | 87 +/- 35 | 91 +/- 34 | 88 +/- 46 | -3% | n.s. | 80 +/- 33 | 81 +/- 25 | +2% | n.s. |
Serum Ferritin | 36.9 +/- 17 | 42.1 +/- 23 | 37.3 +/- 23 | -11% | n.s. |
41.3
+/- 25.1
|
33.4
+/- 22
|
-19%
|
0.004
|
Lithium-WB (ug/L) | 3.6 +/- 6 |
1.82
+/- 0.8
|
10.6
+/-5.1
|
+485%
|
.000001
| 1.60 +/- 0.7 | 1.47 +/- 0.7 | -8% | n.s. |
Magnesium-WB (mg/dL) | 3.64 +/- 0.26 |
3.44
+/- 0.19
|
3.62
+/- 0.25
|
+5%
|
0.00007
|
3.65
+/- 0.41
|
3.81
+/-0.42
|
+4%
|
0.03
|
Magnesium-RBC (ug/g) | 47.5 +/- 5 |
48.6
+/- 7.5
|
44.9
+/- 4.0
|
-8%
|
0.03
| 49.4 +/- 5.8 | 47.9 +/- 6.0 | -3% | n.s. |
Magnesium-Serum (mg/dL) | 2.03 +/- 0.15 | 1.90 +/- 0.13 | 1.95 +/- 0.15 | +2% | n.s. | 1.93 +/- 0.14 | 1.97 +/- 0.15 | +2% | n.s. |
Manganese-WB (ug/L) | 11.6 +/- 3 |
11.0
+/- 3.3
|
13.6
+/- 4.4
|
+23%
|
0.0006
|
12.0
+/- 4.7
|
14.5
+/- 5.0
|
+21%
|
0.00002
|
Manganese-RBC (ug/g) | 0.018 +/- 0.005 | 0.019 +/- 0.007 | 0.019 +/- 0.006 | +1% | n.s. | 0.020 +/- 0.006 | 0.019 +/- 0.007 | -4% | n.s. |
Molybdenum-WB (ug/L) | 1.39 +/- 0.3 |
1.27
+/- 0.23
|
1.88
+/- 0.9
|
+48%
|
0.007*
| 1.34 +/- 0.3 | 1.37 +/- 0.3 | +3% | n.s. |
Molybdenum-RBC (ng/g) | 0.98 +/- 0.2 | 1.01 +/- 0.3 | 1.32 +/- 0.0007 | +31% | 0.06* | 0.87 +/- 0.26 | 0.93 +/- 0.2 | +7% | n.s. |
Phosphorus-RBC (ug/g) | 567 +/- 43 |
587
+/- 73
|
546
+/- 39
|
-7%
|
0.01
|
598
+/- 48
|
564
+/-37
|
-6%
|
0.002
|
Phosphorus-Serum (mg/dL) | 4.58 +/- 0.5 | 4.52 +/- 0.5 | 4.47 +/- 0.6 | -1% | n.s. | 4.57 +/- 0.5 | 4.68 +/- 0.7 | +2% | n.s. |
Potassium -RBC-mEq/L | 76.9 +/- 4.1 | 78.1 +/- 6.2 | 75.5 +/- 4.4 | -3% | n.s. |
81.1
+/- 5.1
|
77.2
+/- 5.1
|
-5%
|
0.01
|
Potassium-Serum mEq/L | 4.17 +/- 0.3 | 4.12 +/- 0.3 | 4.21 +/- 0.3 | +2% | n.s. | 4.01 +/- 0.3 | 4.04 +/- 0.3 | 1% | n.s. |
Selenium-WB (ug/L) | 210 +/- 20 |
209
+/- 25
|
223
+/- 28
|
+7%
|
0.001
|
211
+/- 39
|
218
+/- 44
|
+3%
|
0.05
|
Selenium-RBC (ug/g) | 0.23 +/- 0.03 |
0.251
+/- 0.025
|
0.235
+/- 0.03
|
-6%
|
0.007
|
0.244
+/- 0.052
|
0.221
+/- 0.04
|
-10%
|
0.002
|
Sodium-Serum mEq/L | 137 +/- 1 | 137 +/- 2 | 137 +/- 1 | 0% | n.s. | 138 +/- 3 | 138 +/- 2 | 0% | n.s. |
Vanadium-RBC (ng/g) | 0. 22 +/- 0.07 | 0. 22 +/- 0.09 | 0. 21 +/- 0.05 | -5% | n.s. | 0.21 +/- 0.04 | 0.23 +/- 0.09 | +10% | n.s. |
Zinc-WB (ug/dL) | 555 +/- 74 | 546 +/- 70 | 556 +/- 68 | +2% | n.s. | 559 +/- 59 | 567 +/-59 | +1% | n.s. |
Zinc-RBC (ug/g) | 8.9 +/- 1.4 | 9.1 +/- 1.5 | 8.6 +/- 1.2 | -5% | n.s. | 9.1 +/- 1.1 | 8.8 +/- 1.2 | -3% | n.s. |
Non-essential minerals
| |||||||||
Boron-RBC (ug/g) | 0.025 +/- 0.007 |
0.031
+/- 0.015
|
0.022
+/- 0.008
|
-30%
|
0.004
| 0.025 +/- 0.013 | 0.019 +/- 0.010 | -24% | n.s. |
Strontium-WB (ug/L) | 24 +/- 6 | 21.6 +/- 3.7 | 22.8 +/-4.5 | +6% | n.s. | 29.1 +/- 10 | 28.6 +/-10 | -2% | n.s. |
Treatment Group
Placebo Group
Sulfation, Methylation, Glutathione and Oxidative Stress
Neuro-typicals (n = 44) | Arizona Treatment Group (n = 18) | Arizona Placebo Group (n = 22) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Pre | Post | % change | p-value | Pre | Post | % change | p-value | |||
Free Sulfate (plasma) |
umol/
g-protein
| 4.09 +/- 2.3 |
1.60
+/- 0.6
|
2.93
+/- 2.0
|
+83%
|
0.008
| 1.30 +/- 0.4 | 1.98 +/- 1.8 | +52% | 0.08 |
Total Sulfate (plasma) |
umol/
g-protein
| 1566 +/- 384 |
1150
+/- 254
|
1346
+/- 236
|
+17%
|
0.001
| 1093 +/- 184 | 1163 +/- 194 | +6% | 0.06 |
SAM (RBC) | umol/dl | 228.4 +/- 12 |
218
+/- 17
|
230
+/- 16
|
+6%
|
0.003
|
213
+/- 12
|
218
+/- 13
|
+3%
|
0.005
|
SAH (RBC) | umol/dl | 42.6 +/- 4.4 | 40.7 +/- 7.4 | 41.4 +/- 5.0 | +2% | n.s. |
48.5
+/- 6.9
|
45.4
+/- 7.1
|
-6%
|
0.03
|
Uridine (plasma) | 10-6 M | 7.9 +/- 2.7 |
16.2
+/- 9.5
|
10.4
+/- 4.7
|
-36%
|
0.008
| 16.4 +/- 6.9 | 14.5 +/- 5.8 | -11% | 0.06 |
Adenosine (plasma) | 10-8 M | 20.6 +/- 3.4 | 21.2 +/- 5.3 | 21.0 +/- 3.2 | -1% | n.s. |
24.5
+/- 6.2
|
22.8
+/- 4.2
|
-7%
|
0.05
|
Inosine (plasma) | 10-6 M | 3.83 +/- 0.9 | 3.49 +/- 1.0 | 3.83 +/- 0.6 | +10% | 0.07 | 3.55 +/- 0.9 | 3.49 +/- 1.0 | -2% | n.s. |
Reduced plasma glutathione (GSH) | nmol/ml | 4.09 +/- 0.79 |
3.27
+/- 0.59
|
3.84
+/- 0.61
|
+17%
|
0.0008
| 3.25 +/- 0.38 | 3.40 +/- 0.42 | +5% | n.s. |
Oxidized glutathione (GSSG) | nmol/ml | 0.362 +/- 0.10 |
0.467
+/- 0.12
|
0.403
+/- 0.09
|
-14%
|
0.02
| 0.465 +/- 0.14 | 0.431 +/- 0.11 | -7% | n.s. |
Ratio of oxidized to reduced plasma glutathione | 0.093 +/- 0.04 |
0.150
+/- 0.05
|
0.109
+/- 0.03
|
-27%
|
0.002
| 0.147 +/- 0.05 | 0.132 +/- 0.05 | -10% | n.s. | |
Plasma nitro-tyrosine | ug/l | 7.4 +/- 5.1 |
14.1
+/- 6.5
|
9.9
+/- 5.4
|
-29%
|
0.004
| 19.0 +/0 8.6 | 16.3 +/- 9.2 | -14% | 0.10 |
Treatment Group
Placebo Group
ATP, NADH, NADPH, CoQ10
Units | Neuro-typicals (n = 44) | Arizona Treatment Group (n = 18) | Arizona Placebo Group (n = 22) | |||||||
---|---|---|---|---|---|---|---|---|---|---|
Pre | Post | % change | p-value | Pre | Post | % change | p-value | |||
ATP (plasma) | nmol/l | 18.5 +/- 4.7 |
15.5
+/- 3.7
|
19.3
+/- 2.3
|
+25%
|
0.00001
| 14.0 +/- 4.9 | 15.6 +/- 3.7 | +11% | 0.08 |
NADH (RBC) | nmol/ml | 20.7 +/- 4.3 |
15.7
+/- 4.5
|
20.1
+/- 5.1
|
+28%
|
.00002
| 15.3 +/- 3.9 | 16.4 +/- 4.1 | +8% | 0.06 |
NADPH (RBC) | nmol/ml | 30.9 +/- 8.5 |
23.0
+/- 7.7
|
29.9
+/- 7.1
|
+30%
|
0.001
| 21.9 +/- 5.3 | 23.9 +/- 7.2 | +9% | n.s. |
CoQ10 (plasma) | ug/ml | 0.60 +/- 0.16 |
0.56
+/- 0.14
|
1.41
+/- 0.58
|
+153%
|
0.00001
|
0.57
+/- 0.18
|
0.71
+/- 0.26
|
+26%
|
0.01
|
Treatment Group
Placebo Group
Primary Plasma Amino Acids
Amino Acids | Neuro-typicals (n = 44) | Arizona Treatment Group (n = 18) | Arizona Placebo Group (n = 20) | ||||||
---|---|---|---|---|---|---|---|---|---|
Pre | Post | % change | p-value | Pre | Post | % change | p-value | ||
Histidine | 8.2 +/- 1.3 | 8.7 +/- 2.5 | 9.6 +/- 1.3 | +10% | n.s. | 8.8 +/0 1.5 | 8.0 +/- 1.9 | -9% | n.s. |
Isoleucine | 5.8 +/- 1.6 | 5.3 +/- 1.3 | 5.7 +/- 1.3 | +8% | n.s. |
5.2
+/- 0.8
|
6.0
+/- 1.5
|
16%
|
0.03
|
Leucine | 10.7 +/- 2.1 | 11.0 +/- 2.5 | 11.4 +/- 2.8 | +4% | n.s. | 10.5 +/- 2.0 | 10.4 +/- 1.8 | -1% | n.s. |
Lysine | 14.5 +/- 4.8 | 12.6 +/- 3.8 | 14.8 +/- 4.1 | +17% | 0.10 | 14.2 +/- 3.5 | 14.9 +/- 2.8 | +5% | n.s. |
Methionine | 1.75 +/- 0.34 | 1.84 +/- 0.57 | 2.02 +/- 0.48 | +10% | n.s. | 1.92 +/- 0.45 | 1.93 +/- 0.64 | +1% | n.s. |
Phenylalanine | 4.83 +/- 0.83 | 4.61 +/- 0.55 | 4.68 +/- 1.0 | +2% | n.s. | 4.36 +/- 0.63 | 4.65 +/- 0.66 | +7% | n.s. |
Threonine | 8.88 +/- 2.1 | 9.2 +/- 2.6 | 7.9 +/- 1.8 | -14% | 0.07 | 9.4 +/- 3.6 | 8.7 +/- 2.4 | -7% | n.s. |
Tryptophan | 4.33 +/- 1.0 | 3.32 +/- 0.9 | 4.11 +/- 1.7 | +24% | 0.06 |
3.47
+/- 1.1
|
4.17
+/- 1.3
|
+20%
|
0.04
|
Valine | 20.5 +/- 4.3 | 20.6 +/- 4.3 | 20.0 +/- 4.2 | -3% | n.s. | 18.4 +/- 3.5 | 20.2 +/- 3.7 | +10% | 0.06 |
Alanine | 33.4 +/- 8.9 | 36.6 +/- 9.0 | 37.4 +/- 12 | +2% | n.s. | 36.1 +/- 10 | 36.8 +/- 11 | +2% | n.s. |
Arginine | 6.7 +/- 1.8 |
5.9
+/- 2.2
|
7.5
+/- 1.6
|
+26%
|
0.006
|
6.9
+/- 2.0
|
7.8
+/- 1.5
|
+14%
|
0.02
|
Asparagine | 4.38 +/- 0.83 | 4.50 +/- 1.0 | 4.15 +/- 1.0 | -8% | n.s. | 4.26 +/- 1.42 | 3.92 +/- 0.84 | -8% | n.s. |
Aspartate | 0.82 +/- 0.39 | 0.83 +/- 0.37 | 0.88 +/- 0.33 | +6% | n.s. | 0.69 +/- 0.21 | 0.82 +/- 0.37 | +18% | n.s. |
Cystine + cysteine | 3.48 +/- 0.74 | 3.57 +/- 0.72 | 3.36 +/- 1.2 | -6% | n.s. | 3.01 +/- 0.81 | 3.40 +/- 0.87 | +13% | n.s. |
Glutamate | 5.83 +/- 1.8 | 6.9 +/- 1.5 | 7.66 +/- 1.5 | +12% | n.s. | 6.4 +/- 1.5 | 6.6 +/- 1.5 | +4% | n.s. |
Glutamine | 41.3 +/- 6.8 | 43.1 +/- 8.3 | 38.2 +/- 5.9 | -11% | .08 | 42.4 +/- 11 | 38.4 +/- 5.0 | -10% | 0.10 |
Glycine | 27.3 +/- 10 |
23.8
+/- 6.5
|
28.6
+/- 6.7
|
+20%
|
0.02
| 28.9 +/- 11 | 29.3 +/- 9.1 | +1% | n.s. |
Proline | 15.8 +/- 4.9 | 15.9 +/- 4.2 | 16.0 +/- 4.9 | +1% | n.s. | 15.3 +/- 6.6 | 16.6 +/- 5.7 | +8% | n.s. |
Serine | 9.5 +/- 2.1 |
9.9
+/- 2.1
|
8.9
+/- 1.5
|
-10%
|
0.01
|
10.6
+/- 2.1
|
9.7
+/- 1.8
|
-8%
|
0.01
|
Tyrosine | 6.1 +/- 1.6 | 5.5 +/- 1.3 | 5.9 +/- 1.3 | +6% | n.s. | 5.6 +/- 1.1 | 6.0 +/- 1.3 | +8% | n.s. |
Treatment Group
Placebo Group
Secondary Plasma Amino Acids
Amino Acids | Neuro-typicals (n = 44) | Arizona Treatment Group (n = 18) | Arizona Placebo Group (n = 20) | ||||||
---|---|---|---|---|---|---|---|---|---|
Pre | Post | % change | p-value | Pre | Post | % change | p-value | ||
1-Methyl histidine | 0.355 +/- 0.12 | 0.354 +/- 0.15 | 0.369 +/- 0.10 | +4% | n.s. |
0.407
+/- 0.14
|
0.329
+/- 0.094
|
-19%
|
0.05
|
3-Methyl histidine | 0.68 +/- 0.52 | 0.68 +/- 0.55 | 0.54 +/- 0.46 | -21% | n.s. | 0.83 +/- 0.88 | 0.470 +/- 0.35 | -43% | 0.10 |
Alpha-amino adipate (31%/27% below dl) | 0.088 +/- 0.044 | 0.084 +/- 0.035 | 0.099 +/- 0.052 | +17% | n.s. | 0.079 +/- 0.031 | 0.095 +/- 0.053 | +20% | n.s. |
Alpha-amino-N-butyrate | 1.82 +/- 0.72 | 1.81 +/- 0.60 | 1.55 +/- 0.52 | -15% | n.s. | 1.68 +/- 0.58 | 1.60 +/- 0.50 | -5% | n.s. |
Anserine (84%/95% below dl) | 0.051 +/- 0.005 | 0.055 +/- 0.019 | 0.0054 +/- 0.016 | -1% | n.s. | 0.052 +/- 0.0078 | All results below detectable limit | -3% | n.s. |
Beta-alanine | 0.62 +/- 0.31 | 0.57 +/- 0.23 | 0.60 +/- 0.18 | +6% | n.s. | 0.72 +/- 0.35 | 0.58 +/- 0.16 | -20% | n.s. |
Beta-amino isobutyrate | 0.138 +/- 0.088 | 0.170 +/- 0.070 | 0.162 +/- 0.077 | -5% | n.s. | 0.172 +/- 0.077 | 0.170 +/- 0.072 | -1% | n.s. |
Carnosine (73%/84% below dl) | 0.054 +/- 0.015 | 0.063 +/- 0.042 | (All results below dl) | -21% | n.s. | 0.056 +/- 0.020 | 0.050 +/- 0.001 | -11% | n.s. |
Citrulline | 3.02 +/- 0.52 | 3.02 +/- 0.69 | 3.34 +/- 0.98 | +10% | n.s. | 3.02 +/- 1.0 | 3.15 +/- 0.80 | +4% | n.s. |
Ethanol amine | 0.94 +/- 0.63 | 1.15 +/- 0.90 | 0.81 +/- 0.47 | -29% | n.s. | 0.90 +/- 0.68 | 0.86 +/- 0.41 | -4% | n.s. |
Gamma-amino butyrate (75%/84% below dl) | 0.053 +/- 0.008 | 0.053 +/- 0.08 | 0.053 +/- 0.007 | -1% | n.s. | 0.053 +/- 0.006 | 0.051 +/- 0.004 | -3% | n.s. |
Homocystine + Homocysteine (69%/86% below dl) | 0.0055 +/- 0.0016 |
0.0087
+/- 0.0051
|
0.0057
+/- 0.0014
|
-34%
|
0.02
| 0.0078 +/- 0.0068 | 0.0054 +/- 0.0010 | -30% | n.s. |
Hydroxy proline | 2.19 +/- 0.80 |
2.34
+/- 0.90
|
1.92
+/- 0.58
|
-18%
|
0.03
|
2.54
+/- 0.63
|
2.15
+/- 0.51
|
-15%
|
0.04
|
Methionine Sulfoxide | 0.315 +/- 0.21 | 0.371 +/- 0.22 | 0.335 +/- 0.16 | -10% | n.s. | 0.341 +/- 0.15 | 0.432 +/- 0.30 | +27% | n.s. |
Ornithine | 6.0 +/- 1.7 |
5.0
+/- 1.2
|
6.5
+/- 1.9
|
+29%
|
0.008
| 6.3 +/- 1.8 | 6.00 +/- 1.4 | -5% | n.s. |
Phospho ethanol amine | 1.55 +/- 0.58 | 1.32 +/- 1.0 | 1.53 +/- 0.55 | +16% | n.s. | 1.51 +/- 0.56 | 1.80 +/- 0.56 | +19% | n.s. |
Phospho serine | 0.024 +/- 0.044 | 0.055 +/- 1.0 | 0.015 +/- 0.007 | -73% | n.s. |
0.058
+/- 0.08
|
0.017
+/- 0.009
|
-70%
|
0.05
|
Sarcosine | 0.89 +/- 0.36 |
0.78
+/- 0.32
|
1.06
+/- 0.35
|
+35%
|
0.01
|
0.85
+/- 0.34
|
1.12
+/- 0.38
|
+32%
|
0.01
|
Taurine | 16.8 +/- 5.8 | 13.7 +/- 6.1 | 17.7 +/- 5.7 | +29% | 0.07 |
15.5
+/- 5.8
|
19.9
+/- 5.9
|
+28%
|
0.03
|
Urea | 309 +/- 87 | 329 +/- 105 |
270
+/- 62
|
-18%
|
0.04
| 257 +/- 71 | 252. +/- 106 | -2% | n.s. |
Treatment Group
Placebo Group
Behavioral Results
Effect of Supplement on Symptoms
Placebo-Pre | Placebo-Post | Difference | Supplement- Pre | Supplement Post | Difference | P-Value | |
---|---|---|---|---|---|---|---|
PGI-R (Average Change) | +0.34 +/- 0.54 | +0.67 +/- 0.65 | 0.008 | ||||
ATEC (Total) | 59 +/- 28 | 50 +/- 27 | -9.6 | 63 +/- 22 | 51 +/- 20 | -11.9 | n.s. |
SAS | 5.2 +/- 2.6 | 5.2 +/- 2.6 | 0.0 | 5.4 +/- 2.0 | 5.1 +/- 2.2 | -0.3 | n.s. |
PDD-BI (Autism Composite) | -66 +/- 64 | -79 +/- 68 | -13.4 | -62 +/- 51 | -78 +/- 52 | -16.4 | n.s. |
Placebo Group (n = 51) | Supplement Group (n = 53) | Difference | P-Value | |
---|---|---|---|---|
Expr. Lang. | 0.71 +/- 0.92 | 1.09 +/- 1.11 | 0.39 | 0.06 |
Rec. Lang. |
0.51
+/- 0.81
|
0.91
+/- 1.01
|
0.40
|
0.03
|
Play | 0.51 +/- 0.87 | 0.81 +/- 0.88 | 0.30 | 0.09 |
Cognition | 0.43 +/- 0.84 | 0.74 +/- 1.04 | 0.31 | n.s. |
GI | 0.35 +/- 1.09 | 0.68 +/- 1.11 | 0.33 | n.s. |
Sleep | 0.13 +/- 0.99 | 0.30 +/- 0.87 | 0.17 | n.s. |
Sociability | 0.63 +/- 0.92 | 0.77 +/- 1.00 | 0.15 | n.s. |
Hyperactivity
|
-0.06
+/- 0.55
|
0.31
+/- 0.67
|
0.37
|
0.003
|
Tantrumming
|
-0.10
+/- 0.80
|
0.40
+/- 1.08
|
0.51
|
0.009
|
Eye Contact | 0.40 +/- 0.85 | 0.66 +/- 0.98 | 0.26 | n.s. |
Overall
|
0.56
+/- 0.86
|
1.02
+/- 1.00
|
0.46
|
0.02
|
Average
(of all the other scores)
|
0.34
+/- 0.54
|
0.67
+/- 0.65
|
0.32
|
0.008
|
Medication Effects
Age Effects
Correlation with Biomarkers
Biomarker | Correlation Coefficient (r) | p-value |
---|---|---|
Vitamin K | - 0.74 | p < 0.01 |
Biotin | - 0.67 | p < 0.01 |
Lipoic Acid | + 0.52 | p < 0.05 |
Regression Analysis
PGI-R | |
---|---|
Significant Biomarkers | |
Adjusted R2
| 0.61 |
P-value | 0.0005 |
Primary variables | Vit K (p = 0.03) Biotin (p = 0.04) |