Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

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. 78:749-57.

Materials and methods

Type of study / information:
Type of experience: other: Iron supplementation in human pregnancy - analysis of placebo-controlled studies

Test material

Constituent 1
Reference substance name:
Iron
EC Number:
231-096-4
EC Name:
Iron
Cas Number:
7439-89-6
IUPAC Name:
iron(2+)
Constituent 2
Chemical structure
Reference substance name:
Iron sulphate
EC Number:
231-753-5
EC Name:
Iron sulphate
Cas Number:
7720-78-7
Molecular formula:
FeSO4
IUPAC Name:
Iron (II) sulfate
Details on test material:
The iron formulations ingested by the individuals in the study were described as ferrous iron.

Method

Details on study design:
This publication reviews literature reports of placebo-controlled studies of iron supplementation in pregnancy, the effect of iron supplementation on maternal iron stores, and the effectiveness of iron supplementation in preventing maternal and foetal anaemia.
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.

Results and discussion

Results:
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.

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.