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OSR #1 Update

On 18 June 2010, the FDA wrote to CTI Science questioning whether OSR#1® fit within the agency’s definition of a dietary supplement, indicating that instead it appeared to be a drug.  Although we believe the product meets the legal definition of a “dietary supplement,” we have decided not to contest this point but to work with the agency.  While achieving formal drug approval is lengthy and costly, CTI Science will in the course of it prove to FDA’s satisfaction the safety and efficacy of OSR#1® and ultimately be able to offer OSR#1® to the public with FDA-authorized therapeutic claims.

As a result of this decision, CTI Science has voluntarily agreed to remove OSR#1® from the market effective Thursday, 29 July 2010.  The product will not be available for sale after that date until new drug approval has been obtained.  Please access the CTI Science website, www.ctiscience.com, for updates on OSR#1® in the future.

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Clinical Research

Essential Fatty Acids and AD/HD

Omega Oils - Essential Fatty Acids Valuable in the Treatment of ADHD.

The studies on Essential Fatty Acid levels in Attention Deficit Disorder subjects vs. non- ADD ADHD subjects are interesting.

The ADD ADHD groups had significantly lower concentrations of key essential fatty acids than did the control groups, and about 40% of the ADD ADHD group showed these signs of EFA deficiency:

  • increased thirst
  • frequent urination
  • dry skin
  • dry or brittle hair

Low levels of Omega 6 EFAs contributed to higher incidents of illness (colds, flu, etc.), and deficits in Omega 3 EFAs contributed to problems with learning, behavior, sleep, and temper.

These studies support the case for EFA supplementation as a part of the overall treatment approach to Attention Deficit Disorder - ADHD.

See the discussion on EFAs and Nutraceutical treatment of Attention Deficit Disorder – ADD ADHD.

Benefits from EFA Supplementation in ADHD

Effect of supplementation with polyunsaturated fatty acids and micronutrients on learning and behavior problems associated with child ADHD.

Sinn, N. and Bryan, J. Commonwealth Scientific and Industrial Research Organization Human Nutrition, Adelaide, South Australia.

Methods: Various developmental problems including attention-deficit/hyperactivity disorder (ADHD) have been linked to biological deficiencies in polyunsaturated fatty acids (PUFAs). Additionally, there is evidence that symptoms may be reduced with PUFA supplementation

This study investigated effects of supplementation with PUFAs on symptoms typically associated with ADHD. Because nutrients work synergistically, additional effects of micronutrient supplementation were also investigated.

A total of 132 Australian children aged 7 to 12 years with scores greater than or equal to 2 SD above the population average on the Conners ADHD Index participated in a randomized, placebo-controlled, double-blind intervention over 15 weeks, taking PUFAs alone, PUFAs + micronutrients, or placebo.

Due to unreturned questionnaires, data were only available for 104 children.

Results: Significant medium to strong positive treatment effects were found on parent ratings of core ADHD symptoms, inattention, hyperactivity/impulsivity, on the Conners Parent Rating Scale (CPRS) in both PUFA treatment groups compared with the placebo group; no additional effects were found with the micronutrients.

After a one-way crossover to active supplements in all groups for a further 15 weeks, these results were replicated in the placebo group, and the treatment groups continued to show significant improvements on CPRS core symptoms. No significant effects were found on Conners Teacher Rating Scales.

Conclusion: These results add to preliminary findings that ADHD-related problems with inattention, hyperactivity, and impulsivity might respond to treatment with PUFAs and that improvements may continue with supplementation extending to 30 weeks.

Effects of Fatty Acids on ADHD Symptoms and LDs

A randomized double-blind, placebo-controlled study of the effects of supplementation with highly unsaturated fatty acids on ADHD-related symptoms in children with specific learning difficulties.

Richardson, A.J. and Puri, B.K. University Department of Physiology, Oxford, England, UK.

The authors tested the prediction that relative deficiencies in highly unsaturated fatty acids (HUFAs) may underlie some of the behavioral and learning problems associated with attention-deficit/hyperactivity disorder (ADHD) by studying the effects of HUFA supplementation on ADHD-related symptoms in children with specific learning difficulties (mainly dyslexia) who also showed ADHD features.

Forty-one children aged 8-12 years with both specific learning difficulties and above-average ADHD ratings were randomly allocated to HUFA supplementation or placebo for 12 weeks.

At both baseline and follow-up, a range of behavioral and learning problems associated with ADHD was assessed using standardized parent rating scales.

At baseline, the groups did not differ, but after 12 weeks mean scores for cognitive problems and general behavior problems were significantly lower for the group treated with HUFA than for the placebo group; there were significant improvements from baseline on 7 out of 14 scales for active treatment, compared with none for placebo.

 HUFA supplementation appears to reduce ADHD-related symptoms in children with specific learning difficulties.

Given the safety and tolerability of this simple treatment, results from this pilot study strongly support the case for further investigations.

PMID: 11817499 [PubMed - indexed for MEDLINE]

Essential Fatty Acid Metabolism ADHD

Essential fatty acid metabolism in boys with attention deficit-hyperactivity disorder.

Burgess, J.L. et.al. American Journal of Clinical Nutrition 1995; 62;761-68.

Attention-deficit hyperactivity disorder (ADHD) is the term used to describe children who are inattentive, impulsive, and hyperactive. The cause is unknown and is thought to be multifactorial.

Based on the work of others, we hypothesized that some children with ADHD have altered fatty acid metabolism.

The present study found that 53 subjects with ADHD had significantly lower concentrations of key fatty acids in the plasma polar lipids (20:4n-6, 20:5n-3, and 22:6n-3) and in red blood cell total lipids (20:4n-6 and 22:4n-6) than did the 43 control subjects. Also, a subgroup of 21 subjects with ADHD exhibiting many symptoms of essential fatty acid (EFA) deficiency had significantly lower plasma concentrations of 20:4n-6 and 22:6n-3 than did 32 subjects with ADHD with few EFA-deficiency symptoms.

The data are discussed with respect to cause, but the precise reason for lower fatty acid concentrations in some children with ADHD is not clear.

Flax Seed Oil and Vitamin C with ADHD

Supplementation with flax oil and vitamin C improves the outcome of Attention Deficit Hyperactivity Disorder (ADHD).

Joshi, K., Lad, S., Kale, M., Patwardhan, B., Mahadik, S.P., Patni, B., Chaudhary, A., Bhave, S., Pandit, A. Interdisciplinary School of Health Sciences, University of Pune, Ganeshkhind, Pune-411007, Maharashtra, India.

Considerable clinical and experimental evidence now supports the idea that deficiencies or imbalances in certain highly unsaturated fatty acids may contribute to a range of common developmental disorders including Attention Deficit Hyperactivity Disorder (ADHD).

This pilot study evaluates the effect of alpha linolenic acid (ALA)-rich nutritional supplementation in the form of flax oil and antioxidant emulsion on blood fatty acids composition and behavior in children with ADHD. Post-supplementation levels of RBC membrane fatty acids were significantly higher than pretreatment levels as well as the levels in control.

There was significant improvement in the symptoms of ADHD reflected by reduction in total hyperactivity scores of ADHD children derived from ADHD rating scale.

PMID: 16314082 [PubMed - indexed for MEDLINE]

Oxford-Durham Study: Fatty Acids ADHD and DCD

The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder.

Richardson, A.J., Montgomery, P. University Laboratory of Physiology, Parks Road, Oxford OX1 3PT, United Kingdom.

Background: Developmental coordination disorder (DCD) affects approximately 5% of school-aged children. In addition to the core deficits in motor function, this condition is associated commonly with difficulties in learning, behavior, and psychosocial adjustment that persist into adulthood.

Mounting evidence suggests that a relative lack of certain polyunsaturated fatty acids may contribute to related neurodevelopmental and psychiatric disorders such as dyslexia and attention-deficit/hyperactivity disorder. Given the current lack of effective, evidence-based treatment options for DCD, the use of fatty acid supplements merits investigation.

Methods: A randomized, controlled trial of dietary supplementation with omega-3 and omega-6 fatty acids, compared with placebo, was conducted with 117 children with DCD (5-12 years of age). Treatment for 3 months in parallel groups was followed by a 1-way crossover from placebo to active treatment for an additional 3 months.

Results: No effect of treatment on motor skills was apparent, but significant improvements for active treatment versus placebo were found in reading, spelling, and behavior over 3 months of treatment in parallel groups.

After the crossover, similar changes were seen in the placebo-active group, whereas children continuing with active treatment maintained or improved their progress.

Conclusions: Fatty acid supplementation may offer a safe efficacious treatment option for educational and behavioral problems among children with DCD.

Additional work is needed to investigate whether our inability to detect any improvement in motor skills reflects the measures used and to assess the durability of treatment effects on behavior and academic progress.

PMID: 15867048 [PubMed - indexed for MEDLINE]

Polyunsaturated Fatty Acids in ADHD

Long-chain polyunsaturated fatty acids in children with attention-deficit hyperactivity disorder.

Burgess, J.R., et.al. American Journal of Clinical Nutrition 2000, Vol. 71, No. 1, 327-330.

Several previous studies indicated that some physical symptoms reported in ADHD are similar to symptoms observed in essential fatty acid (EFA) deficiency in animals and humans deprived of EFAs.

We reported previously that a subgroup of ADHD subjects reporting many symptoms indicative of EFA deficiency (L-ADHD) had significantly lower proportions of plasma arachidonic acid and docosahexaenoic acid than did ADHD subjects with few such symptoms or control subjects.

In another study using contrast analysis of the plasma polar lipid data, subjects with lower compositions of total n-3 fatty acids had significantly more behavioral problems, temper tantrums, and learning, health, and sleep problems than did those with high proportions of n-3 fatty acids.

The reasons for the lower proportions of long-chain polyunsaturated fatty acids (LCPUFAs) in these children are not clear; however, factors involving fatty acid intake, conversion of EFAs to LCPUFA products, and enhanced metabolism are discussed.

Sonja Mak, European College of Neuropsychopharmacology

ADHD and Stress in Children: Brain Scans

As parents of ADHD kids know all too well, children with ADHD often have difficulty handling stress, or stressful situations. Now, a team of researchers in Australia may have found a biological reason why this is so.

Brain scans of children with ADHD.The researchers studied brain scans of 24 ADHD children (with hyperactivity) and found that the right parietal lobes in children with ADHD did not function as well as in children without ADHD. The right parietal lobes are associated with the development of coping strategies.

Prof. Vance, who is based at Melbourne's Royal Children's Hospital, says these children will do anything to feel in control of their situation. They have negative, oppositional ways of relating, for instance, changing the rules of a game endlessly and arguing back. "This discovery has the real potential to improve treatment strategies for ADHD, to enable these children to better manage the demands of their family and school relationships," he said. "It cannot be assumed that ADHD behavior is the fault of bad parenting or lack or discipline."

Further studies into brain regions and key environmental factors are underway to add to this research, published in the journal Molecular Psychiatry.