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

Primary Purpose

Iron Deficiency Anemia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron
Gelatin
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Iron Deficiency Anemia focused on measuring iron deficiency anemia (IDA), iron status, mother-infant interactions, intervention study, postpartum depressive symptoms

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Iron Intervention

    Placebo

    Arm Description

    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).

    IS mothers will receive 600 mg of gelatin daily for 4.5 months in the postpartum period (6 weeks to 6 months post delivery).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 4, 2019
    Last Updated
    October 20, 2020
    Sponsor
    Penn State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03944733
    Brief Title
    Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions
    Acronym
    IDinteract
    Official Title
    Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was never started as a result of change of personnel and funding
    Study Start Date
    December 1, 2019 (Anticipated)
    Primary Completion Date
    December 30, 2020 (Anticipated)
    Study Completion Date
    December 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Penn State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency Anemia
    Keywords
    iron deficiency anemia (IDA), iron status, mother-infant interactions, intervention study, postpartum depressive symptoms

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    A study staff not involved with data analyses or outcome assessment will provide the intervention to participants.
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Iron Intervention
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    IS mothers will receive 600 mg of gelatin daily for 4.5 months in the postpartum period (6 weeks to 6 months post delivery).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Iron
    Other Intervention Name(s)
    Iron, Spring Valley
    Intervention Description
    65 mg of iron (ferrous sulfate)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Gelatin
    Other Intervention Name(s)
    21st Century
    Intervention Description
    600 mg gelatin
    Primary Outcome Measure Information:
    Title
    Mother-child interaction scores in the postpartum period
    Description
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura E Murray-Kolb, PhD
    Organizational Affiliation
    Penn State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19158210
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20431398
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17041272
    Citation
    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.
    Results Reference
    background

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

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