Prospective Open Pilot of Low vs. Higher Dose Vitamin D in D-deficient Asthmatic Children: Does Diet Predict Immune Function and Asthma Symptom Response to Vitamin D Supplementation?
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- vitamin D levels
研究概览
简要总结
This is a pilot randomized controlled trial of lower vs. higher dose vitamin D supplementation in D-deficient asthmatic children, to determine necessary sample sizes for outcome measures in a larger multisite study, and to examine possible relationships and effect sizes between various biological markers that may be important to the pathophysiology of childhood asthma.
Aims of the study are to:
- Evaluate effect sizes for relationships between serum 25OH-vitD and omega-fatty acid (FA) biomarkers, before and after supplementation with lower or higher dose vitamin D, on immune function, and asthma severity.
- Characterize changes in innate and adaptive immune function and inflammatory responses in asthmatic D-deficient youth at baseline and after vitD supplements, by dietary O6:O3FA status and vitD dose.
详细描述
An estimated up to 120 youth meeting eligibility criteria will be screened for vitamin D deficiency, and if found deficient, will be offered enrollment in this study.
Eligible children who assent and whose parent/guardian consent to participate will be randomized to low dose vs. higher dose vitamin D to take across a 3-month period of time. Blood, questionnaires, and pulmonary function tests will be obtained at baseline and end of study. Weekly phone calls will check on any questions or concerns the participant or their family may have.
Aims and Hypotheses:
Aim I: Evaluate effect sizes for relationships between omega-FA and vitD biomarkers, pre- and post- low and higher dose vitamin D supplementation, in diet, immune function, and asthma severity.
Aim II: Characterize changes in innate and adaptive immune function and inflammatory responses in asthmatic D-deficient youth at baseline and after vitD supplements, by O6:O3FA status and vitD dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent and assent signed and dated before participation.
- •Male or female, ages 8 through 17 at baseline; all races and ethnicities
- •asthma and currently taking a prescribed daily inhaled steroid asthma medication
- •English-speaking with at least one English-speaking parent
- •vitamin D deficiency (<20 ng/mL)
- •compliant with attending at least 2/4 of their last asthma-related scheduled clinic visits
排除标准
- •If female, pregnant, planning to become pregnant, and/or sexually active and not using reliable contraception
- •Unable to provide informed consent (mental retardation, etc)
- •Current substance dependence (within the past 2 months)
- •Known metabolic bone disease, including rickets
- •Known malabsorption disease: Crohn's, ulcerative colitis, celiac sprue
- •Has begun new treatment with vitamin D (>600 IU/day) within the past month
- •Treatment with prednisone or other oral or IV steroid within the past 4 weeks
- •Taking mineral oil or thiazide diuretics on a daily basis
- •Acute or chronic liver, renal, endocrine, neurologic, infectious, autoimmune, cardiac, pulmonary, gastrointestinal, hematologic, metabolic disorder or any other disorder, per study physician judgment.
- •Severe treatment noncompliance documented in medical record or by managing provider report.
- •Our definition of a highly effective method of birth control is consistent with ICH Guidance for Industry M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (April 1997) when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner. Subjects will also be reminded to use condoms to prevent sexually transmitted diseases and as a second method toward birth control.
研究组 & 干预措施
Vitamin D lower dose
800 IU vitamin D3 by mouth each day for 3 months
干预措施: Vitamin D3 (Drug)
vitamin D2 + vitamin D3
Vitamin D2 50,000 IU each week x 4 + vitamin D3 4,000 IU each day for 3 months
干预措施: Vitamin D2 + vitamin D3 (Drug)
结局指标
主要结局
vitamin D levels
时间窗: change in serum vitamin D level from baseline to 12 weeks
Primary: 1. 25-OH vitamin D (D2, D3): 1.0 ml sample sent to Esoterix Laboratory Services (Austin, TX) through NCH and run via high pressure liquid chromatography (HPLC), Tandem Mass Spectrometry analysis. Samples processed individually, not batched, for intervention study purposes.
次要结局
- Block Kids 2004 Food Frequency Questionnaire(baseline, and end of week 12)
- immune status(baseline, and end of week 12)
- Side Effects Form for Children and Adolescents (SEFCA)(Baseline, end of week 12)
研究者
Barbara Gracious
Principal Investigator
Nationwide Children's Hospital