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Recruitment Status : Withdrawn (The study was never started as a result of change of personnel and funding)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
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia||Dietary Supplement: Iron Dietary Supplement: Gelatin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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.|
|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|
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
- 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.
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
|Principal Investigator:||Laura E Murray-Kolb, PhD||Penn State University|