Vitamin D Supplementation in Breastfeeding Women

Study Overview
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Brief Summary
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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.

Official Title
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Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum

Conditions
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Vitamin D Deficiency, Rickets, Infant Nutrition Disorders

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D 150,000 units once<br>Single dose of vitamin D3 150,000 IU given orally once | Dietary Supplement: Vitamin D3<br>* 150,000 IU orally given once<br>* Other names: Cholecalciferol;|
| Experimental: Vitamin D 5000 units daily<br>Vitamin D3 5000 IU daily given orally for 28 days | Dietary Supplement: Vitamin D3<br>* 5000 IU given orally daily for 28 days<br>* Other names: Cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of days of detectable milk vitamin D concentrations | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D deficiency, Rickets, Infant, Nutrition