- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240265
Vitamin D Supplementation in Breastfeeding Women
April 26, 2013 updated by: Thomas Thacher, Mayo Clinic
Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum
Adequate vitamin D is essential for proper infant growth and development.
However, human milk is low in vitamin D, and most infants do not receive recommended supplementation.
Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation.
Forty non-pregnant, lactating women at least 18 years of age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single dose.
Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium; maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 50 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion criteria
- Currently lactating mothers at least 18 years of age
- Willing to continue exclusively breastfeeding their infant throughout the study interval
- The infant is 1-6 months of age at the beginning of the study
- Willing and able to participate in all aspects of the study
- Mother and infant are in good health, as determined by the study investigator
- Have been provided with, understand, and have signed the informed consent for themselves and their child.
Exclusion criteria
- Have recently travelled (within the preceding 30 days) or plan to travel south of 35 degrees north latitude during the study interval
- Have recently or plan to engage in indoor tanning
- Are currently taking medications that affect vitamin D metabolism, like steroids, anticonvulsants, or barbiturates
- Are nursing multiple infants (e.g. twins)
- Are taking greater than the daily recommended intake of 1000 mg elemental calcium as calcium supplements
- Are taking greater than the standard daily dose of 400 IU of vitamin D found in prenatal vitamins
- Infant weight below 1.67 kg
- Mothers with baseline 25(OH)D levels >70 ng/ml, and/or infants with baseline 25(OH)D levels >70 ng/ml
- History of kidney stones
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin D 150,000 units once
Single dose of vitamin D3 150,000 IU given orally once
|
150,000 IU orally given once
Other Names:
5000 IU given orally daily for 28 days
Other Names:
|
Experimental: Vitamin D 5000 units daily
Vitamin D3 5000 IU daily given orally for 28 days
|
150,000 IU orally given once
Other Names:
5000 IU given orally daily for 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of days of detectable milk vitamin D concentrations
Time Frame: 28 days
|
To compare the number of days of detectable milk vitamin D concentrations and incremental area under the curve between two dosing regimens of oral cholecalciferol in lactating mothers.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant serum 25(OH)D concentration
Time Frame: 28 days
|
To compare the change in serum 25(OH)D concentrations in infants receiving milk from mothers supplemented with either 5,000 IU daily or 150,000 IU monthly cholecalciferol
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Thacher, MD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ketha H, Thacher TD, Oberhelman SS, Fischer PR, Singh RJ, Kumar R. Comparison of the effect of daily versus bolus dose maternal vitamin D3 supplementation on the 24,25-dihydroxyvitamin D3 to 25-hydroxyvitamin D3 ratio. Bone. 2018 May;110:321-325. doi: 10.1016/j.bone.2018.02.024. Epub 2018 Feb 24.
- Oberhelman SS, Meekins ME, Fischer PR, Lee BR, Singh RJ, Cha SS, Gardner BM, Pettifor JM, Croghan IT, Thacher TD. Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1378-87. doi: 10.1016/j.mayocp.2013.09.012.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
November 10, 2010
First Submitted That Met QC Criteria
November 10, 2010
First Posted (Estimate)
November 15, 2010
Study Record Updates
Last Update Posted (Estimate)
April 30, 2013
Last Update Submitted That Met QC Criteria
April 26, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Musculoskeletal Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Bone Diseases, Metabolic
- Calcium Metabolism Disorders
- Vitamin D Deficiency
- Nutrition Disorders
- Rickets
- Infant Nutrition Disorders
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- 10-004130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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