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

Iron Deficiency Anemia Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03944733
• Other study ID #: 00009190
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: October 2020
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Depression
• Iron Deficiency Anemia

Intervention

Dietary Supplement:
• Iron
65 mg of iron (ferrous sulfate)
• Gelatin
600 mg gelatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year