Neodecanoic acid, zinc salt, basic

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:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

The Effects of Zinc Supplements on Plasma Zinc and Copper Levels and the Reported Symptoms in Healthy Volunteers

Author:

Samman S & Roberts DCK

Year:

1987

Bibliographic source:

Med. J. Aust. 146:246-249

Materials and methods

Study type:

study with volunteers

Endpoint addressed:

repeated dose toxicity: oral

Principles of method if other than guideline:

A double-blind cross-over trial was conducted on healthy human volunteers for 12 wks to evaluate the effect of the test material on plasma Cu & Zn levels.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Zinc sulphate

EC Number:

231-793-3

EC Name:

Zinc sulphate

Cas Number:

7733-02-0

Molecular formula:

H2O4S.Zn

IUPAC Name:

zinc sulfate

Details on test material:

- Name of test material (as cited in study report): Zinc sulfate
- Other: Obtained from Zincaps, Protea Pharmaceuticals

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 47
- Sex: 26 female and 21 male
- Demographic information: Volunteers were students or staffs members of University of Sydney; females weighing less than males
- Other: Subjects were asked not to change their lifestyle pattern and particularly habits known to alter lipid metabolism (ingestion of alcohol, diet, exercise and smoking)

Ethical approval:

confirmed and informed consent free of coercion received

Route of exposure:

oral

Reason of exposure:

intentional

Exposure assessment:

measured

Details on exposure:

Double-blind cross-over trial, 50 mg Zn (as 220 mg ZnSO4) or placebo (lactose) was administered to healthy volunteers three times a day for six weeks. Volunteers were allocated randomly to Zn treatment for six weeks followed by placebo regimen for six weeks, or vice versa.

Examinations:

- Estimation of plasma Cu & Zn levels: Measured by atomic absorption spectrophotometry (Varian, AA-575)

Medical treatment:

No

Results and discussion

Clinical signs:

- Headache, abdominal cramps, nausea, loss of appetite and vomiting in 84 % females & 18 % males, increased plasma levels in men (36 %) & women (57 %)
- Six females discontinued the trial; five owing to gastric irritation and one owing to consistent headaches.

Results of examinations:

- Plasma Zn levels: Increased in men (36 %) & women (57 %)
- Plasma Cu levels: Remains unchanged in male/female

Effectivity of medical treatment:

Not applicable

Outcome of incidence:

Not applicable

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Under the test conditions, the test material was considered to have no effect on plasma Cu levels. The gastric discomfort associated with Zn supplementation may be related to body weight as the symptoms were reported from the lower-weight volunteers.

Executive summary:

A double-blind cross-over trial was conducted on 47 (26 female & 21 male) healthy human volunteers for 12 wks to evaluate the effect of the test material (50 mg Zn as ZnSO4 or placebo, three times a day, for six weeks) on plasma Cu and Zn levels.

Headache, abdominal cramps, nausea, loss of apetite and vomiting was reported in 84 % females & 18 % males. The test material increased the plasma Zn levels in men (36 %) & women (57 %) whereas plasma Cu levels remain unchanged.

Under the test conditions, the test material was considered to have no effect on plasma Cu levels. The gastric discomfort associated with Zn supplementation may be related to body weight as the symptoms were reported from the lower-weight volunteers.