Vitamin D3 Supplementation Pilot Study

Vitamin D Deficiency Clinical Trial

Official title:

Pilot Study of Vitamin D3 Supplementation and Outcomes in Vitamin D Deficient Obese, African American Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01546103
• Other study ID #: 11-008075
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: January 22, 2013
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Cholecalciferol
1000 IU by mouth, once daily for 3 months.
• Cholecalciferol
5000 IU by mouth, once daily for 3 months.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25OHD before and after treatment	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.	12 weeks	Yes
Secondary	Adiponectin level comparison	Adiponectin level comparison before and at post-treatment	12 weeks	Yes
Secondary	Lipid panel comparison	Lipid panel comparison before and at post-treatment	12 weeks	Yes
Secondary	Lipoprotein subclass particles comparison	Lipoprotein subclass particles comparison before and at post-treatment	12 weeks	Yes
Secondary	High-sensitivity C-Reactive Protein (hsCRP) comparison	High-sensitivity C-Reactive Protein (hsCRP) comparison before and at post-treatment	12 weeks	Yes
Secondary	Insulin level comparison	Insulin level comparison before and at post-treatment	12 weeks	Yes
Secondary	Total and undercarboxylated osteocalcin level comparison	Total and undercarboxylated osteocalcin level comparison before and at post-treatment	12 weeks	Yes
Secondary	Muscle strength comparison	Muscle strength comparison before and at post-treatment	12 weeks	Yes
Secondary	Musculoskeletal pain comparison	Musculoskeletal pain comparison before and at post-treatment	12 weeks	Yes
Secondary	Blood pressure comparison	Blood pressure comparison before and at post-treatment	12 weeks	Yes