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Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions (IDinteract)

Primary Purpose

Iron Deficiency Anemia

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Iron

Gelatin

About this trial

This is an interventional other trial for Iron Deficiency Anemia focused on measuring iron deficiency anemia (IDA), iron status, mother-infant interactions, intervention study, postpartum depressive symptoms

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Pregnant women between 18 - 40 years.
Mother expects to be the primary caregiver for the infant for study duration and will allow infant to be enrolled in the study..
Mother has no history of gastrointestinal or hematological disorders and not taking medications that interfere with hematopoiesis or absorption.
After birth, the mother and baby are healthy, delivery was of one infant only, infant gestational age ≥ 38 weeks, infant weight ≥ 2500 g (5.5 lbs), neither the mom nor the infant received a blood transfusion at or since delivery, and mom agrees to discontinue use of any iron containing medications.

Exclusion Criteria:

Maternal age ≤ 18 and > 40 years
Evidence of a history of gastrointestinal or hematological disorders and evidence of taking medications that interfere with hematopoiesis or absorption.
Severely anemic (Hemoglobin < 90 g/L)
Iron deficient but not anemic women
Non-English speaking

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Iron Intervention

Placebo

Arm Description

IDA mothers will receive a 65 mg of iron (ferrous sulfate) daily for 4.5 months in the postpartum period (6 weeks to 6 months post delivery).

IS mothers will receive 600 mg of gelatin daily for 4.5 months in the postpartum period (6 weeks to 6 months post delivery).

Outcomes

Primary Outcome Measures

Mother-child interaction scores in the postpartum period

Mother child-interactions will be measured via the Emotional Availability Scales and microanalytic coding. Scores will be compared between iron deficient and iron sufficient women. Investigators will also examine change in scores within group from baseline to endline. The Emotional Availability Scales consist of 6 subscales, 4 for the mother and 2 for the child. Maternal subscales include sensitivity, structuring, non-intrusiveness, and non-hostility; child subscales include involvement and responsiveness. All are scored on a scale of 1 - 7 with higher scores indicating a more optimal score.

Secondary Outcome Measures

Full Information

NCT ID

NCT03944733

First Posted

April 4, 2019

Last Updated

October 20, 2020

Sponsor

Penn State University

1. Study Identification

Unique Protocol Identification Number

NCT03944733

Brief Title

Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions

Acronym

IDinteract

Official Title

Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Withdrawn

Why Stopped

The study was never started as a result of change of personnel and funding

Study Start Date

December 1, 2019 (Anticipated)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Penn State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study aims to examine the relation between iron status and maternal-child interactions as well as maternal depressive symptoms in mothers from central Pennsylvania.

Detailed Description

Investigators aim to follow mothers and their infants from 6 weeks to 6 months in the postpartum to understand the relation between iron status and mother-child interactions and depressive symptoms. During this period, iron deficient anemic mothers will receive an intervention with iron with the scope of improving iron status, reducing their depressive symptoms, and in turn, increasing the quality of parenting behaviors during mother-child interactions. The control group will be iron sufficient mothers who will receive a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

Keywords

iron deficiency anemia (IDA), iron status, mother-infant interactions, intervention study, postpartum depressive symptoms

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Iron deficient anemic (IDA) mothers will be given an iron supplement versus iron sufficient (control; CN) mothers will be given a placebo (gelatin pill) daily.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

A study staff not involved with data analyses or outcome assessment will provide the intervention to participants.

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iron Intervention

Arm Type

Active Comparator

Arm Description

IDA mothers will receive a 65 mg of iron (ferrous sulfate) daily for 4.5 months in the postpartum period (6 weeks to 6 months post delivery).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

IS mothers will receive 600 mg of gelatin daily for 4.5 months in the postpartum period (6 weeks to 6 months post delivery).

Intervention Type

Dietary Supplement

Intervention Name(s)

Iron

Other Intervention Name(s)

Iron, Spring Valley

Intervention Description

65 mg of iron (ferrous sulfate)

Intervention Type

Dietary Supplement

Intervention Name(s)

Gelatin

Other Intervention Name(s)

21st Century

Intervention Description

600 mg gelatin

Primary Outcome Measure Information:

Title

Mother-child interaction scores in the postpartum period

Description

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pregnant women between 18 - 40 years. Mother expects to be the primary caregiver for the infant for study duration and will allow infant to be enrolled in the study.. Mother has no history of gastrointestinal or hematological disorders and not taking medications that interfere with hematopoiesis or absorption. After birth, the mother and baby are healthy, delivery was of one infant only, infant gestational age ≥ 38 weeks, infant weight ≥ 2500 g (5.5 lbs), neither the mom nor the infant received a blood transfusion at or since delivery, and mom agrees to discontinue use of any iron containing medications. Exclusion Criteria: Maternal age ≤ 18 and > 40 years Evidence of a history of gastrointestinal or hematological disorders and evidence of taking medications that interfere with hematopoiesis or absorption. Severely anemic (Hemoglobin < 90 g/L) Iron deficient but not anemic women Non-English speaking

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura E Murray-Kolb, PhD

Organizational Affiliation

Penn State University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19158210

Citation

Murray-Kolb LE, Beard JL. Iron deficiency and child and maternal health. Am J Clin Nutr. 2009 Mar;89(3):946S-950S. doi: 10.3945/ajcn.2008.26692D. Epub 2009 Jan 21.

Results Reference

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PubMed Identifier

20431398

Citation

Armony-Sivan R, Kaplan-Estrin M, Jacobson SW, Lozoff B. Iron-deficiency anemia in infancy and mother-infant interaction during feeding. J Dev Behav Pediatr. 2010 May;31(4):326-32. doi: 10.1097/DBP.0b013e3181dc525d.

Results Reference

background

PubMed Identifier

17041272

Citation

Corapci F, Radan AE, Lozoff B. Iron deficiency in infancy and mother-child interaction at 5 years. J Dev Behav Pediatr. 2006 Oct;27(5):371-8. doi: 10.1097/00004703-200610000-00001.

Results Reference

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Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions

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