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

NCT03944733 | Withdrawn

• 1 other identifier: 00009190
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Deficiency Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Iron Intervention

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Iron DIETARY_SUPPLEMENT

65 mg of iron (ferrous sulfate)

Also known as: Iron, Spring Valley

Iron Intervention

Gelatin DIETARY_SUPPLEMENT

600 mg gelatin

Also known as: 21st Century

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Related Publications (3)

• 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.

  PMID: 19158210 BACKGROUND

• 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.

  PMID: 20431398 BACKGROUND

• 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.

  PMID: 17041272 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Iron; Gelatin

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Laura E Murray-Kolb, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A study staff not involved with data analyses or outcome assessment will provide the intervention to participants.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: May 9, 2019
• Study Start: December 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share