Iron trinitrate

Exposure related observations in humans: other data

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

Test material information

Constituent 1

Reference substance name:

Iron sulphate

EC Number:

231-753-5

EC Name:

Iron sulphate

Cas Number:

7720-78-7

IUPAC Name:

iron(2+) sulfate

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.