Vitamin D Supplementation in Breastfeeding Women

NCT01240265 | Completed Phase 2

• 1 other identifier: 10-004130
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Rickets; Infant Nutrition Disorders

Keywords

Vitamin D deficiency; Rickets; Infant; Nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Infant serum 25(OH)D concentration

  28 days

Study Arms (2)

Vitamin D 150,000 units once

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Vitamin D 5000 units daily

EXPERIMENTAL

Vitamin D3 5000 IU daily given orally for 28 days

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

150,000 IU orally given once

Also known as: Cholecalciferol

Vitamin D 150,000 units once

Eligibility Criteria

• Age: 1 Month - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 29486367 DERIVED

• 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.

  PMID: 24290111 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Rickets; Infant Nutrition Disorders

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Calcium Metabolism Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Thomas Thacher, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 15, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 30, 2013

Record last verified: 2013-04

Locations

US (1)