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

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ClinicalTrials.gov Identifier: NCT03944733
Recruitment Status : Withdrawn (The study was never started as a result of change of personnel and funding)
First Posted : May 9, 2019
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Laura E Murray-Kolb, Penn State University

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Dietary Supplement: Iron Dietary Supplement: Gelatin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A study staff not involved with data analyses or outcome assessment will provide the intervention to participants.
Primary Purpose: Other
Official Title: Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions Iron

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 Name: 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 Name: 21st Century




Primary Outcome Measures :
  1. Mother-child interaction scores in the postpartum period [ Time Frame: 1 year ]

    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.




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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944733


Sponsors and Collaborators
Penn State University
Investigators
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Principal Investigator: Laura E Murray-Kolb, PhD Penn State University
Publications:
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Responsible Party: Laura E Murray-Kolb, Associate Professor and Professor-in-Charge of the Graduate Program, Penn State University
ClinicalTrials.gov Identifier: NCT03944733    
Other Study ID Numbers: 00009190
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laura E Murray-Kolb, Penn State University:
iron deficiency anemia (IDA)
iron status
mother-infant interactions
intervention study
postpartum depressive symptoms
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Depression
Anemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Behavioral Symptoms
Iron
Trace Elements
Micronutrients
Physiological Effects of Drugs