Calcium bis(2-ethylhexanoate)

Health surveillance data

Administrative data

Endpoint:

health surveillance data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

no data available

Reliability:

other: not rated acc. to Klimisch

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Well-documented study on Ca supplementation to young pregnant women to prevent preterm delivery. In the current study, calcium was supplemented to humans in the form of calcium carbonate. The carbonate ion is released as CO2 following reaction with gastric juice and is therefore toxicologically not relevant. The objective of the study was the evaluation of any effects of calcium.

Data source

Reference

Reference Type:

publication

Title:

Calcium supplementation during pregnancy may reduce preterm delivery in high-risk populations

Author:

Villar, J.; Repke, J.T.

Year:

1990

Bibliographic source:

Am. J. Obstet. Gynecol, Vol. 163, No. 4, Part 1, 1124-1131

Materials and methods

Study type:

medical monitoring

Endpoint addressed:

developmental toxicity / teratogenicity

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Medical monitoring, double-blind controlled clinical trial of calcium supplementation during pregnancy

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Calcium carbonate

EC Number:

207-439-9

EC Name:

Calcium carbonate

Cas Number:

471-34-1

Molecular formula:

CaCO3

IUPAC Name:

calcium carbonate

Details on test material:

- Name of test material (as cited in study report): Calcium carbonate
- Physical state: solid
No further details are given.

Method

Type of population:

general

Ethical approval:

not specified

Details on study design:

All participants were 17 years of age or less and clinically healthy. Patients were enrolled by the 21st week of gestation. The mean duration of supplementation with 2.0 g Ca or placebo was approximately 14 weeks. The Ca tablets contained 500 mg of elemental Ca as CaCO3. 94 women received 3.0 (±1.4) tablets per day in the Ca group and 95 women received 2.8 (±1.5) tablets per day in the placebo group. Dietary Ca intake was similar in both groups at about 1200 mg/day.

Results and discussion

Results:

The Ca group had a lower incidence of preterm delivery (< 27 weeks; 7.4% vs. 21.1%; p=0.007); spontaneous labour and preterm delivery (6.4% vs. 17.9%; p=0.01), and low birth weight (9.6% vs. 21.1%; p=0.03). This effect was also present after stratified analysis by level of treatment compliance, urinary tract infection, and chlamydial infection. Life-table analysis demonstrated an overall shift to a higher gestational age in the Ca group compared with the placebo group.

Applicant's summary and conclusion

Conclusions:

The calcium group had a lower incidence of preterm delivery, spontaneous labour and preterm delivery, and low birth weight. This effect was also present after stratified analysis by level of treatment compliance, urinary tract infection, and chlamydial infection. Life-table analysis demonstrated an overall shift to a higher gestational age in the calcium supplemented group compared with the placebo group.