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Vitamin D Supplementation in Breastfeeding Women

NCT ID: NCT01240265

Last Updated: 2013-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-08-31

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.

Detailed Description

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Conditions

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Vitamin D Deficiency Rickets Infant Nutrition Disorders

Keywords

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Vitamin D deficiency Rickets Infant Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vitamin D 150,000 units once

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

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

150,000 IU orally given once

Vitamin D 5000 units daily

Vitamin D3 5000 IU daily given orally for 28 days

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

5000 IU given orally daily for 28 days

Interventions

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Vitamin D3

150,000 IU orally given once

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3

5000 IU given orally daily for 28 days

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol Cholecalciferol

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Thomas Thacher

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Thacher, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29486367 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24290111 (View on PubMed)

Other Identifiers

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10-004130

Identifier Type: -

Identifier Source: org_study_id