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Lactating women for Breastmilk Expression

N/A

Recruiting

Led By Thomas Thatcher, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female and male infants who are exclusively breastfed

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 28

Awards & highlights

Study Summary

This trial aims to measure the nutritional value of vitamin D in breastmilk for infants by examining their saliva and gut. Additionally, it will measure the levels of vitamin D sulfates in breastmilk

Who is the study for?

This trial is for breastfeeding mothers and their infants. Mothers must be currently lactating and willing to take Vitamin D supplements for 28 days. Infants involved should be receiving breastmilk. Participants with known conditions that affect vitamin D metabolism or allergies to Vitamin D supplements cannot join.Check my eligibility

What is being tested?

The study measures the levels of Vitamin D sulfates in breastmilk and its nutritional value in an infant's saliva and gut after mothers take Vitamin D supplements for a month.See study design

What are the potential side effects?

Vitamin D supplementation generally has minimal side effects, which may include mild digestive discomfort or allergic reactions in rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My infant is only fed breast milk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Vitamin D sulfate levels in breastmilk

Secondary outcome measures

Vitamin D sulfate levels in infant digesta

Vitamin D sulfate levels in infant saliva

Side effects data

From 2016 Phase 4 trial • 1366 Patients • NCT01709110

12%

Back pain

Arthralgia

Fall

Hip fracture

Humerus fracture

Lumbar vertebral fracture

Osteoarthritis

Femur fracture

100%

80%

60%

40%

20%

Study treatment Arm

Risedronate

Teriparatide

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lactating womenExperimental Treatment1 Intervention

Subjects identified as having delivered an infant and lactating will receive Vitamin D3 for 28 days.

Group II: Breastfeeding InfantsActive Control1 Intervention

No intervention will be administered.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D

2013

Completed Phase 4

~3470

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,215 Previous Clinical Trials

3,767,183 Total Patients Enrolled

Thomas Thatcher, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this research study?

"To be eligible for participation in this clinical trial, individuals must be between the ages of 1 month and 60 years old. Additionally, breastmilk expression is required. The study aims to enroll approximately 60 participants."

Answered by AI

Are individuals who have surpassed the age of 80 eligible to participate in this ongoing clinical trial?

"To participate in this clinical trial, eligible candidates must fall within the age range of 1 month to 60 years. There are a total of 16 trials available for patients under the age of 18 and an additional 23 trials specifically designed for individuals over the age of 65."

Answered by AI

Is the enrollment process currently open for this research study?

"Apologies for the confusion. According to the information on clinicaltrials.gov, this particular trial is not currently seeking candidates as of its last update on 1/2/2024. However, it is worth noting that there are currently 44 other studies actively recruiting participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vitamin D Sulfates in Breastmilk

Thomas Thacher 2023. "Vitamin D Sulfates in Breastmilk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06203041.

All > Vitamin D Deficiency > Paid Studies Minneapolis