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出境医 / 临床实验 / Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions (IDinteract)

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

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.

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.
Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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.



Eligibility Criteria
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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
Contacts and Locations

Sponsors and Collaborators
Penn State University
Investigators
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Principal Investigator: Laura E Murray-Kolb, PhD Penn State University
Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date October 22, 2020
Estimated Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019) 		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. We will also examine change in scores within group from baseline to endline.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions
Official Title  ICMJE Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Iron Deficiency Anemia
Intervention  ICMJE
  • Dietary Supplement: Iron
    65 mg of iron (ferrous sulfate)
    Other Name: Iron, Spring Valley
  • Dietary Supplement: Gelatin
    600 mg gelatin
    Other Name: 21st Century
Study Arms  ICMJE
  • 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).
    Intervention: 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).
    Intervention: Dietary Supplement: Gelatin
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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 20, 2020) 		0
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2019) 		200
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03944733
Other Study ID Numbers  ICMJE 00009190
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laura E Murray-Kolb, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura E Murray-Kolb, PhD Penn State University
PRS Account Penn State University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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