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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03944733
Acronym
IDinteract
Enrollment
0
Registered
2019-05-09
Start date
2019-12-01
Completion date
2020-12-30
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTIron

65 mg of iron (ferrous sulfate)

DIETARY_SUPPLEMENTGelatin

600 mg gelatin

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mother-child interaction scores in the postpartum period1 yearMother 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026