Iron Status, Maternal Depressive Symptoms, and Mother-child Interactions (IDinteract)

The Pennsylvania State University (PENNSTATE)

Status: Withdrawn

Conditions: Iron Deficiency Anemia

Treatments: Dietary Supplement: Iron; Dietary Supplement: Gelatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03944733

00009190

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups, including a placebo group

Iron Intervention

Active Comparator group

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).

Treatment:

Dietary Supplement: Iron

Placebo

Placebo Comparator group

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).

Treatment:

Dietary Supplement: Gelatin