NCT02558725

Brief Summary

Since normal pregnancies are associated with dilutional anemia, due to a greater increase in plasma volume with a smaller increase in RBC mass, it is important to properly diagnose IDA according to the levels of serum ferritin. Previous studies examining the optimal iron dose have shown that adjustment of iron supplementation according to serum ferritin levels in early pregnancy could be beneficial. Nonetheless, there is no consensus regarding the appropriate dose of iron during pregnancy, its dose-response curve and its effect on serum ferritin levels. In this trial the investigators sought to assess the efficacy of doubling the daily iron supplement dose in pregnant women with IDA.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

September 22, 2015

Last Update Submit

December 28, 2015

Conditions

Pregnancy Complications, Hematologic

Outcome Measures

Primary Outcomes (1)

  • mean hemoglobin level

    at 35 weeks gestation

Secondary Outcomes (7)

  • mean ferritin level

    at 35 weeks

  • mean hemoglobin level

    at 6 weeks post-partum

  • incidence of constipation

    every 2 weeks from 20th week to 40th week

  • birth-weights

    at delivery

  • mean ferritin level

    6 weeks after delivery

  • +2 more secondary outcomes

Study Arms (2)

one capsule of iron supplement

NO INTERVENTION

instructed to take one capsule at least 2 hours after consumption of dairy products

two capsules of iron supplement

ACTIVE COMPARATOR

instructed to take two capsules of Aktiferrin F at least 2 hours after consumption of dairy products

Drug: two capsules of aktiferrin F

Interventions

two capsules of aktiferrin FDRUG

two capsules of Aktiferrin F or Foliferrin

Also known as: Foliferrin
two capsules of iron supplement

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy pregnant women ages 18-42
  • A diagnosis of iron deficiency anemia (defined as a hemoglobin concentration \<10.5 g/dL and ferritin levels \< 15 ng/ml) between 16-19 weeks
  • Full access to medical computerized files.

You may not qualify if:

  • Hyperemesis gravidarum continuing past 20 weeks of gestation
  • Thalassemia
  • Abnormal blood smears
  • Vitamin D deficiency
  • Mal-absorption disorders (inflammable bowel diseases; Crohn's, Ulcerative Colitis)
  • Chronic diseases associated with anemia (i.e SLE).
  • Deterioration in hemoglobin levels mandating IV iron administration
  • More than 3 capsules missed at the 2 weeks check-up
  • diarrhea lasting more than 5 days
  • Vomiting lasting more than 5 days less than 2 hours after supplement ingestion
  • Administration of blood products during pregnancy
  • Use of multi-vitamin supplements containing iron
  • Hospitalization periods greater than two weeks
  • A time period shorter than 15 weeks from allocation to delivery -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta Medical Center

Tel Aviv, Israel

RECRUITING

Related Publications (1)

  • Shinar S, Skornick-Rapaport A, Maslovitz S. Iron supplementation in singleton pregnancy: Is there a benefit to doubling the dose of elemental iron in iron-deficient pregnant women? a randomized controlled trial. J Perinatol. 2017 Jul;37(7):782-786. doi: 10.1038/jp.2017.43. Epub 2017 Apr 6.

    PMID: 28383533DERIVED

MeSH Terms

Conditions

Pregnancy Complications, Hematologic

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sharon Maslovitz, Dr

    Maccabi Healthcare Services, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Maslovitz, Dr

CONTACT

0527360048maslovitz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 24, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

IL(1)