Myo-inositol

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

Inositol Safety: Clinical Evidences

Author:

Carlomagno G and Unfer V

Year:

2011

Bibliographic source:

European Review for Medical and Pharmacological Sciences, 15:931-936

Materials and methods

Study type:

clinical case study

Endpoint addressed:

repeated dose toxicity: oral

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Clinical trials ranging from 1 to 12 months were carried out in order to evaluate the effects of the test substance in pathologic conditions, mainly neuropsychiatric disease (depression, Alzheimer disease, panic disorder) and polycystic ovary syndrome (PCOS).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Myo-inositol

EC Number:

201-781-2

EC Name:

Myo-inositol

Cas Number:

87-89-8

Molecular formula:

C6H12O6

IUPAC Name:

cyclohexane-1,2,3,4,5,6-hexol

Test material form:

solid

Details on test material:

- Purity: not reported

Method

Type of population:

other: patients with pathologic conditions (depresskon, Alzheimer disease, panic disorder, and polycystic ovary syndrome)

Ethical approval:

not specified

Route of exposure:

oral

Reason of exposure:

intentional

Exposure assessment:

measured

Details on exposure:

Patients were orally administered the test substance for treatment of neuropsychiatric disease (depression, Alzheimer disease, panic disorder) and polycystic ovary syndrome (PCOS). Dose levels ranged from 4 to 30 g/day (equal to 67 to 500 mg/kg bw/day for a 60 kg person), and the duration of the treatments ranged from 1 to 12 months.

Results and discussion

Outcome of incidence:

No mortality was reported. The most frequently reported symptoms were flatulence, loose stool, or diarrhea. Mild gastrointestinal symptoms were experienced for the first month only. Additional symptoms included mild insomnia, nausea, increased glycemia, sleepiness, tiredness, and/or headache.

Applicant's summary and conclusion

Conclusions:

No mortality was reported in clincal trials with the test substance at doses up to 30 g/day. The test substance at doses greater than 12 g/day induced mild gastrointestinal side effects such as nausea, flatus and diarrhoea.

Executive summary:

Data from 12 controlled clinical trials in a total of 250 adults given oral doses of 4 to 30 g inositol/person per day (equal to 67 and 500 mg/kg bw per day for a 60 kg person) over 1 to 12 months were reviewed.No mortality was reported. The most frequently reported symptoms were flatulence, loose stool, or diarrhoea. Mild gastrointestinal symptoms were experienced for the first month only. Additional symptoms included mild insomnia, nausea, increased glycemia, sleepiness, tiredness, and/or headache.