Prevention of Vitamin D Deficiency

Prevention of Vitamin D Deficiency in Breastfed Infants

Breastfed infants living in a northern location (41 degrees N) are at high risk of vitamin D deficiency during winter. This trial is designed to determine how much supplemental vitamin D breastfed infants need to receive in order to remain free of vitamin D deficiency

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day

Detailed Description

It is increasingly being recognized that infants and children living at northern latitudes are at risk of vitamin D deficiency, especially if their skin is darkly pigmented. The study by the PI (Pediatrics 2006;118:603) was the first to demonstrate that infants with light skin pigmentation living at 41 degrees north are at risk of vitamin D deficiency. During winter (December - April) a full 78% of infants were vitamin D deficient if they did not receive vitamin D from an external source. Very few breastfed babies are currently receiving supplemental vitamin D. The recommended dose is 200 IU/day. However, there are questions about the adequacy of this dose of vitamin D for the prevention of vitamin D deficiency. The present trial is designed to determine whether a dose of 200 IU/day is effective or whether doses of 400 IU/day, 600 IU/day or 800 IU/day are required to prevent vitamin D deficiency reliably.

The trial is a randomized, prospective double-blind trial in which breastfed infants will receive 200 IU/day or 400 IU/day or 600 IU/day or 800 IU/day from 1 to 9 months of age. There will not be a placebo control group. Infants will be followed through 12 months of age. Normal term infants (birth weight >2500 g) who are born in June through November will be enrolled and randomized at 1 month of age. They will visit the study center at monthly intervals and will have capillary blood drawn at select ages. At 2 months and again in March or April whole body mineral content will be determined by DEXA. Infants will not be permitted to receive formula until 9 months of age. They may receive complementary foods beginning at 4 months of age. Vitamin D supplements will be weighed before dispensing and again when the empty and half-empty containers are returned. Study endpoints will be blood parameters and bone mineral content determined at the end of winter, i.e., between March and May 15. Blood parameters include 25-OHD, parathyroid hormone, calcium, alkaline phosphatase, osteocalcin, N-telopeptide, ferritin and transferrin receptor. 180 infants will be enrolled at 1 month of age in the expectation that 48 per group will complete the trial to at least 9 months of age.

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Coralville, Iowa, United States, 52241-8802
      • MTF, 2501 Crosspark Rd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Term infant
• No major congenital malformations
• Less than one month old
• Breastfed, no other foods

Exclusion Criteria:

• Formula feeding
• Premature birth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 200 IU/day Vitamin D	Dietary supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day; Infants receive daily 0.5 ml of code labeled supplement
Experimental: 400 IU/day Vitamin D	Dietary supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day; Infants receive daily 0.5 ml of code labeled supplement
Experimental: 600 IU/day Vitamin D	Dietary supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day; Infants receive daily 0.5 ml of code labeled supplement
Experimental: 800 IU/day Vitamin D	Dietary supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day; Infants receive daily 0.5 ml of code labeled supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase	end of winter

Secondary Outcome Measures

Outcome Measure	Time Frame
whole body mineral content by DEXA	end of winter

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• Ziegler EE, Nelson SE, Jeter JM. Vitamin D supplementation of breastfed infants: a randomized dose-response trial. Pediatr Res. 2014 Aug;76(2):177-83. doi: 10.1038/pr.2014.76. Epub 2014 May 23.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: June 28, 2007
• First Submitted That Met QC Criteria: June 28, 2007
• First Posted (Estimate): June 29, 2007

Study Record Updates

• Last Update Posted (Estimate): December 18, 2012
• Last Update Submitted That Met QC Criteria: December 14, 2012
• Last Verified: September 1, 2006

More Information

Terms related to this study

• Keywords: winter; vitamin D status; infant; vitamin D deficiency; breastfed infant; northern latitude; breastfed
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: R01HD048870 (U.S. NIH Grant/Contract)