Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Vitamin D Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00494104
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Tracking Information
First Submitted Date  ICMJE June 28, 2007
First Posted Date  ICMJE June 29, 2007
Last Update Posted Date December 18, 2012
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2007)
Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase [ Time Frame: end of winter ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2007)
whole body mineral content by DEXA [ Time Frame: end of winter ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Vitamin D Deficiency
Official Title  ICMJE Prevention of Vitamin D Deficiency in Breastfed Infants
Brief Summary 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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Vitamin D Deficiency
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: 200 IU/day Vitamin D
    200 IU/day Vitamin D
    Intervention: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
  • Experimental: 400 IU/day Vitamin D
    400 IU/day Vitamin D
    Intervention: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
  • Experimental: 600 IU/day Vitamin D
    600 IU/day Vitamin D
    Intervention: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
  • Experimental: 800 IU/day Vitamin D
    800 IU/day Vitamin D
    Intervention: Dietary Supplement: Vitamin D drops, 200 or 400 or 600 IU/day or 800 IU/day
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2012)
398
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2007)
180
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Formula feeding
  • Premature birth
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00494104
Other Study ID Numbers  ICMJE R01HD048870( U.S. NIH Grant/Contract )
R01HD048870 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ekhard Ziegler, MD University of Iowa
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP