Clinical trial NCT03944733: Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions
Official title: Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: iron deficiency anemia (IDA)
iron status
mother-infant interactions
intervention study
postpartum depressive symptoms
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Mother-child interaction scores in the postpartum period
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Penn State University
name: Laura E Murray-Kolb, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.