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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Publication, reasonably documented, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Iron status and iron balance during pregnancy.A critical reappraisal of iron supplementation.
Author:
Milman N, Bergholt T, Byg K-E
Year:
1999
Bibliographic source:
Acta. Obstet. Gynecol. Scand. 78: 749-757.

Materials and methods

Type of study / information:
Type of experience: other: Iron supplementation in human pregnancy - analysis of placebo-controlled studies
Endpoint addressed:
other: effects of iron supplementation during pregnancy
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Analysis of placebo-controlled studies of the effects of iron supplementation on iron blood levels and pregnancy outcome.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
The iron formulations ingested by the individuals in the study were described as ferrous iron.

Method

Ethical approval:
not applicable
Remarks:
review of published studies
Exposure assessment:
measured

Results and discussion

Results:
Iron treated women had greater iron reserves, higher haemoglobin and lower incidence of iron-deficiency anaemia than placebo treated women, both in pregnancy and postpartum. Children born to iron-treated women had higher serum ferritin levels than those born to placebo-treated women. Birth weight is decreased at low haemoglobin levels of 86 g/l and at high levels of > 145 g/l

Applicant's summary and conclusion

Conclusions:
This investigation based on literature studies placebo controlled studies of supplementation concluded that supplementation with 65 mg/day from 20 weeks of gestation is sufficient to prevent iron deficiency anaemia. One study concluded that birth weight is decreased at low haemoglobin levels of <86 g/l and at high levels of > 145 g/l. However, in eight placebo-controlled studies, no harmful effects of supplementation during pregnancy on birth weight of infants or frequency of perinatal complications were discovered.
Executive summary:

A literature review of placebo-controlled studies published between 1975 and 1997 was carried out. The serum ferritin concentrations of placebo  

treated women were compared with those of iron-treated women, during and after pregnancy.
The effect of supplementation on peri-natal complications and birth weight wasconsidered.

Iron treated women had greater iron reserves, higher haemoglobin and lower incidence of iron-deficiency anaemia than placebo treated women, both 

in pregnancy and postpartum. Children born to iron-treated women had higher serum ferritin levels than those born to placebo-treated women. Birth 

weight is decreased at low haemoglobin levels of <86 g/l and at high levels of > 145 g/l.

This investigation based on literature studies placebo controlled studies of supplementation concluded that supplementation with 65 mg/day from 20 weeks of gestation is sufficient to prevent iron deficiency anaemia. One study concluded that birth weight is decreased at low haemoglobin levels of

<86 g/l and at high levels of > 145 g/l. However, in eight placebo-controlled studies, no harmful effects of supplementation during pregnancy on birth weight of infants or frequency of perinatal complications were discovered.