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

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.

Study Overview

• Status: Withdrawn
• Conditions: Iron Deficiency Anemia
• Intervention / Treatment: Dietary supplement: Iron; Dietary supplement: Gelatin

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Pregnant women between 18 - 40 years.
2. Mother expects to be the primary caregiver for the infant for study duration and will allow infant to be enrolled in the study..
3. Mother has no history of gastrointestinal or hematological disorders and not taking medications that interfere with hematopoiesis or absorption.
4. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Iron Intervention; 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).	Dietary supplement: Iron; 65 mg of iron (ferrous sulfate); Other Names: Iron, Spring Valley
Placebo Comparator: Placebo; IS mothers will receive 600 mg of gelatin daily for 4.5 months in the postpartum period (6 weeks to 6 months post delivery).	Dietary supplement: Gelatin; 600 mg gelatin; Other Names: 21st Century

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: Laura E Murray-Kolb, PhD, Penn State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2019
• Primary Completion (Estimated): December 30, 2020
• Study Completion (Estimated): December 30, 2020

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 9, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: intervention study; iron status; iron deficiency anemia (IDA); mother-infant interactions; postpartum depressive symptoms
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia, Iron-Deficiency; Amino Acids, Peptides, and Proteins; Proteins; Inorganic Chemicals; Elements; Metals; Metals, Heavy; Transition Elements; Scleroproteins; Iron; Gelatin
• Other Study ID Numbers: 00009190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No