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Vitamin D Supplementation in Breastfeeding Women

Primary Purpose

Vitamin D Deficiency, Rickets, Infant Nutrition Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Vitamin D3

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D deficiency, Rickets, Infant, Nutrition

Eligibility Criteria

1 Month - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Vitamin D 150,000 units once

Vitamin D 5000 units daily

Arm Description

Single dose of vitamin D3 150,000 IU given orally once

Vitamin D3 5000 IU daily given orally for 28 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01240265

First Posted

November 10, 2010

Last Updated

April 26, 2013

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT01240265

Brief Title

Vitamin D Supplementation in Breastfeeding Women

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency, Rickets, Infant Nutrition Disorders

Keywords

Vitamin D deficiency, Rickets, Infant, Nutrition

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D 150,000 units once

Arm Type

Experimental

Arm Description

Single dose of vitamin D3 150,000 IU given orally once

Arm Title

Vitamin D 5000 units daily

Arm Type

Experimental

Arm Description

Vitamin D3 5000 IU daily given orally for 28 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Cholecalciferol

Intervention Description

150,000 IU orally given once

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Cholecalciferol

Intervention Description

5000 IU given orally daily for 28 days

Primary Outcome Measure Information:

Title

The number of days of detectable milk vitamin D concentrations

Description

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.

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Infant serum 25(OH)D concentration

Description

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

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Thacher, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29486367

Citation

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.

Results Reference

derived

PubMed Identifier

24290111

Citation

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.

Results Reference

derived

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Vitamin D Supplementation in Breastfeeding Women

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