Vitamin D for Maternal Stress

Recruiting at 1 trial location

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Idaho

Disqualifiers: Mothers <18 years, infants survival <72 hours

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Vitamin D (Cholecalciferol) for reducing maternal stress?

Research suggests that low levels of vitamin D in pregnant women are linked to higher chances of depression, which is a form of stress. Studies have found that women with better vitamin D levels tend to have fewer depressive symptoms during and after pregnancy. ^{1 2 3 4 5}

Is Vitamin D supplementation safe for pregnant and breastfeeding women?

Vitamin D supplementation of 1,000–2,000 international units per day is generally considered safe during pregnancy. A study found that even higher doses, like 6,400 IU per day, were safe for breastfeeding mothers and their infants, with no significant safety concerns. ^{6 7 8 9 10}

How does the drug Vitamin D (Cholecalciferol) differ from other treatments for maternal stress?

Vitamin D (Cholecalciferol) is unique because it addresses maternal stress by potentially improving vitamin D levels, which are often low during pregnancy and linked to depression and anxiety. Unlike other treatments, it focuses on correcting a nutritional deficiency that may contribute to stress and mood disorders in pregnant women. ^{2 3 4 5 11}

What is the purpose of this trial?

Mothers of preterm infants experience exaggerated emotional stressors compared to those typically associated with new motherhood, making these women particularly vulnerable to postpartum depression. As many as 70% of mothers of preterm infants experience postpartum depression compared to only 12.5% of those delivering full-term infants. Increased stress and depression during this critical period are detrimental because they hamper a mother's ability to care for her infant and are associated with increased neonatal sepsis and mortality, decreased neonatal growth, and delayed motor and cognitive development. Postpartum depression is also associated with excessive maternal weight gain and risk for metabolic diseases, anxiety, and sleep disturbances. Stress in breastfeeding mothers can also alter circulating concentrations of some bioactive components (e.g., immunoglobulins, cortisol) that can transfer into milk. As such, understanding factors predisposing these vulnerable women to extreme levels of stress and finding ways to lower this stress and lessen its negative health outcomes on mothers and infants are important public health challenges. The March of Dimes estimates that 8.5% of births in Idaho are preterm, making this topic particularly relevant for Idaho women. Risk factors for postpartum depression in mothers delivering term or preterm infants are complex, but maternal nutrient deficiencies may be involved. Vitamin D status, for instance, is inversely correlated with risk of postpartum depression in women delivering term infants. However, vitamin D interventions have yielded inconsistent results, perhaps due to confounding impacts of geographic location, skin color, and endogenous vitamin D synthesis. Endogenous vitamin D synthesis requires cutaneous sunlight exposure, placing Idaho women at even greater risk of vitamin D deficiency - particularly in the winter when days are extremely short (only 7 hr on the winter solstice). The impact of maternal vitamin D supplementation during lactation on infant variables (e.g., vitamin D status) has been examined. However, its effect on maternal mental health has not been rigorously studied - let alone in the 'frontier and remote' (FAR) rural West, including Idaho, with short periods of wintertime sunlight and poor access to healthcare. Our long term goal is to develop interventions to improve maternal and infant health in Idaho - particularly in the context of preterm births. The overall primary objective of this proposal is to determine if maternal vitamin D supplementation improves vitamin D status and mental health in Idahoan mothers of preterm infants. Our central hypothesis is that vitamin D supplementation improves vitamin D status and reduces stress and other indicators of poor postpartum maternal mental health in Idaho women delivering preterm infants. Secondarily, we will assess the effects of maternal vitamin D supplementation on human milk composition.

Eligibility Criteria

This trial is for mothers in Idaho who have recently given birth to preterm infants and are experiencing high levels of stress, which may lead to postpartum depression. Participants should not have other factors that could affect mental health or milk composition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vitamin D supplementation or placebo to assess its impact on maternal mental health and milk composition

8 weeks

3 visits (in-person) at baseline, 4-week, and 8-week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Vitamin D (Cholecalciferol)

Trial Overview The study tests if Vitamin D supplements can improve the mental health of these mothers and alter the composition of their breast milk. It compares the effects of Vitamin D against a placebo in a controlled environment.

Participant Groups

Group I: Vitamin D Experimental Treatment 1 Intervention

Group II: Placebo Control Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Idaho

Lead Sponsor

Trials

21

Recruited

2,800+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Maternal early-pregnancy vitamin D status is associated with maternal depressive symptoms in the Amsterdam Born Children and Their Development cohort. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Implications of vitamin D deficiency in pregnancy and lactation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Poor vitamin D status and the risk of maternal depression: a dose-response meta-analysis of observational studies. [2023]

4. Austria pubmed.ncbi.nlm.nih.gov

Vitamin D deficiency and depressive symptoms in the perinatal period. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Association of serum vitamin D with symptoms of depression and anxiety in early pregnancy. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

ACOG Committee Opinion No. 495: Vitamin D: Screening and supplementation during pregnancy. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Breastfeeding woman are at higher risk of vitamin D deficiency than non-breastfeeding women - insights from the German VitaMinFemin study. [2019]

8. India pubmed.ncbi.nlm.nih.gov

Vitamin D in pregnancy: A metabolic outlook. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Vitamin D: Before, during and after Pregnancy: Effect on Neonates and Children. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Safety Aspects of a Randomized Clinical Trial of Maternal and Infant Vitamin D Supplementation by Feeding Type Through 7 Months Postpartum. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Low vitamin D levels are associated with symptoms of depression in young adult males. [2022]