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WithdrawnNCT03944733IDinteractUpdated Nov 20, 2025

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

An interventional study of Iron and Gelatin in Iron Deficiency Anemia, sponsored by Penn State University. Withdrawn. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Penn State University · Not applicable, Interventional, and Other

Why this study was withdrawn
The study was never started as a result of change of personnel and funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Iron Deficiency Anemia

Keywords

  • iron deficiency anemia (IDA)
  • iron status
  • mother-infant interactions
  • intervention study
  • postpartum depressive symptoms
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementIron

    65 mg of iron (ferrous sulfate)

    Also known as: Iron, Spring Valley

  • Dietary supplementGelatin

    600 mg gelatin

    Also known as: 21st Century

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 19158210 ↗
  • 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. PubMed 20431398 ↗
  • 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. PubMed 17041272 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03944733
Lead sponsor
Penn State University
Responsible party
Sponsor
First posted
May 9, 2019
Start date
Dec 1, 2019 (estimated)
Primary completion
Dec 30, 2020 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Nov 20, 2025

Study contacts

Laura E Murray-Kolb, PhD
principal investigator · Penn State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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