Vitamin D3 Supplementation Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01546103
First received: January 4, 2012
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

The purpose of this research study is to determine whether taking vitamin D, every day, over a 12 week period will improve the vitamin D status, risks for poor heart health, risks for developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers with low vitamin D levels.


Condition Intervention
Vitamin D Deficiency
Dietary Supplement: Cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Vitamin D3 Supplementation and Outcomes in Vitamin D Deficient Obese, African American Adolescents

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Serum 25OHD before and after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    The analysis will be an intention-to-treat method in which subjects are assumed to obtain all vitamin D supplements from the study and from no other sources, and all subjects are assumed to comply with their assigned dose and daily use. For the main contrasts of interest (5000 IU vs 1000 IU doses as well as serum 25OHD concentrations), we propose a longitudinal mixed effects model with time measurements at 0 and 12 weeks.


Secondary Outcome Measures:
  • Adiponectin level comparison [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Adiponectin level comparison before and at post-treatment

  • Lipid panel comparison [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Lipid panel comparison before and at post-treatment

  • Lipoprotein subclass particles comparison [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Lipoprotein subclass particles comparison before and at post-treatment

  • High-sensitivity C-Reactive Protein (hsCRP) comparison [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    High-sensitivity C-Reactive Protein (hsCRP) comparison before and at post-treatment

  • Insulin level comparison [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Insulin level comparison before and at post-treatment

  • Total and undercarboxylated osteocalcin level comparison [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Total and undercarboxylated osteocalcin level comparison before and at post-treatment

  • Muscle strength comparison [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Muscle strength comparison before and at post-treatment

  • Musculoskeletal pain comparison [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Musculoskeletal pain comparison before and at post-treatment

  • Blood pressure comparison [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Blood pressure comparison before and at post-treatment


Enrollment: 39
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D3 supplementation of 1000 IU Dietary Supplement: Cholecalciferol
1000 IU by mouth, once daily for 3 months.
Other Name: Vitamin D
Active Comparator: Vitamin D3 supplementation of 5000 IU Dietary Supplement: Cholecalciferol
5000 IU by mouth, once daily for 3 months.
Other Name: Vitamin D

Detailed Description:

Vitamin D deficiency/insufficiency is common throughout the lifespan, and across all race and ethnic groups. The American Academy of Pediatrics (AAP) recently recommended supplementation dose to 400 international units (IU) daily in all children. These recommendations target rickets prevention, but address neither the vitamin D supplementation necessary to optimize bone health nor the nontraditional vitamin D roles in immune disease, insulin resistance, muscle function, and cardiovascular disease (CVD). Moreover, the AAP recommendation noted that it had little pediatric data upon which to base guidelines. The Institute of Medicine also recently published Dietary Reference Intakes for Calcium and Vitamin D: the estimated average requirement in children and adults was set at 400(IU) daily and the recommend dietary allowance was set at 600 IU daily. Data on outcomes and supplementation levels in African Americans (a population at particular risk for vitamin D deficiency) and across pediatric age ranges and body habitus types, are lacking. The Vitamin D supplementation requirement in obese, African American adolescents is particularly problematic since obesity is associated with 1) lower circulating vitamin D levels (25OHD) and 2) insulin resistance. This pilot study will examine the effect of vitamin D supplementation upon 25OHD, the serum marker of vitamin D status, in obese, African American adolescents with vitamin D deficiency. Subjects will be randomized to receive cholecalciferol 1000 IU or 5000 IU daily for 3 months. Serum 25OHD, parathyroid hormone, glucose, insulin, CVD risk markers, and measures of muscle function and pain will be obtained at baseline and post-treatment. This pilot study will provide data on serum 25OHD responses to vitamin D at doses more likely to meaningfully impact 25OHD than the current American Academy of Pediatrics (AAP) supplementation guideline. Responses to supplementation can then inform future clinical trials aimed at addressing outcomes of vitamin D replacement on insulin sensitivity and CVD risk in obese adolescents.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • African American
  • Obese [body mass index (BMI) greater than or equal to 95th percentile for age and sex]
  • Pubertal (Tanner Stage greater than 1)
  • 25OHD less than 20 ng/mL (for treatment phase); if 25OHD is greater than or equal to 20 ng/mL, only baseline data will be obtained.
  • Committed to adherence to supplementation and study completion

Exclusion Criteria:

  • Pregnancy
  • Chronic medical conditions or medications use that can affect growth, nutrition, bone health, vitamin D metabolism, glucose, or insulin sensitivity
  • Known history of hypercalcemia or hypercalciuria
  • Non-English speaking, as assessments are available only in English
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546103

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Sheela N Magge, MD, MSCE Children's Hospital of Philadelphia
Principal Investigator: Andrea Kelly, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01546103     History of Changes
Other Study ID Numbers: 11-008075
Study First Received: January 4, 2012
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Vitamin D deficiency

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 16, 2014