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Vitamin D for Infants' Nutrition

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
Must not have
Lactating mothers with history of renal disease
Breastfeeding infants with known gastrointestinal diseases that require medical treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 28
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am a breastfeeding mother with a history of kidney problems.
Select...
My breastfeeding infant has a diagnosed gastrointestinal disease needing treatment.
Select...
I am a breastfeeding mother with a history of sarcoidosis.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Vitamin D sulfate levels in breastmilk
Secondary study objectives
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
7%
Arthralgia
3%
Fall
1%
Humerus fracture
1%
Hip fracture
1%
Lumbar vertebral fracture
1%
Osteoarthritis
1%
Femur fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Risedronate
Teriparatide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3670

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,901 Total Patients Enrolled
3 Trials studying Vitamin D Deficiency
119 Patients Enrolled for Vitamin D Deficiency
Thomas Thatcher, MDPrincipal InvestigatorMayo Clinic
~38 spots leftby Dec 2026
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