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Withdrawn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
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
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
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
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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