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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Iron Deficiency Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

A study staff not involved with data analyses or outcome assessment will provide the intervention to participants.

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Iron

Intervention Type DIETARY_SUPPLEMENT

65 mg of iron (ferrous sulfate)

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).

Group Type PLACEBO_COMPARATOR

Gelatin

Intervention Type DIETARY_SUPPLEMENT

600 mg gelatin

Interventions

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Iron

65 mg of iron (ferrous sulfate)

Intervention Type DIETARY_SUPPLEMENT

Gelatin

600 mg gelatin

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Iron, Spring Valley 21st Century

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes