The Effect of Particle Size of Calcium Carbonate and Vitamin D on Calcium and Bone Parameters in Adolescent Girls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Calcium Balance
研究概览
简要总结
This study has two research arms:
The purpose of the 1st is to determine if a smaller particle size calcium carbonate supplement (than that which is now commercially available) improves calcium absorption and retention in adolescents girls.
The purpose of the 2nd is to determine if vitamin D supplementation improves calcium absorption and retention in adolescents girls.
详细描述
An important strategy to reducing the risk for osteoporosis and fracture in later life is to optimize the development of peak bone mass during adolescence. Because calcium is the main mineral component of bone, maximizing calcium absorption and retention during adolescence is important to maximize peak bone mass.
Our two research arms address two different mechanisms by which calcium absorption and retention may be increased:
- We hypothesize that a smaller particle size calcium carbonate supplement (than that which is now commercially available) may be better absorbed and lead to higher calcium retention in adolescents.
- We hypothesize that vitamin D supplementation will increased calcium absorption and retention in adolescents.
Subjects will be assigned to one of the two research arms.
1)Small and large particle size calcium supplements or placebo or 2) calcium supplements with or without vitamin D supplements will be given to subjects during two 3-week study periods in which subjects live on-site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •12-14 year old girls
- •Generally Healthy
排除标准
- •History of alcohol, smoking, or non-prescription drug use
- •Malabsorptive disorders, bone, liver, or kidney disease that may affect calcium metabolism
- •Oral contraceptive use
- •Pregnancy
研究组 & 干预措施
Small Particle Size Calcium Carbonate
Subjects are given small particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
干预措施: Small Particle Size Calcium Carbonate Supplement (Dietary Supplement)
Large Particle Size Calcium Carbonate
Subjects are given a large particle size calcium carbonate supplement twice daily (total of 625 mg/d from supplement).
干预措施: Large Particle Size Calcium Carbonate Supplement (Dietary Supplement)
Calcium Placebo
Subjects are given two placebo tablets daily, which are identical to the large and small particle size calcium carbonate supplements.
干预措施: Calcium Placebo (Dietary Supplement)
No Vitamin D supplement
Subjects are given calcium carbonate supplement once daily (325 mg/d from supplement).
干预措施: Small Particle Size Calcium Carbonate Supplement (Dietary Supplement)
Vitamin D supplement
Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.
干预措施: Small Particle Size Calcium Carbonate Supplement (Dietary Supplement)
Vitamin D supplement
Subjects are given a calcium supplement once daily (325 mg/d from supplement) with 1000 IU/d vitamin D supplement.
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Calcium Balance
时间窗: weeks 2,3 + 5,6
Total calcium(Ca) retention will be calculated - Ca retention/d = Ca intake/d - Ca excretion/d (urine + feces)
Calcium Absorption
时间窗: Day 15, 30
次要结局
- Serum parathyroid hormone suppression(Day 19, 40)
- Serum 25-hydroxyvitamin D(Day 1, 20, 2, 41)
- Urinary Calcium(Weeks 2,3 + 5,6)
- Fecal Calcium(Weeks 2,3 + 5,6)
研究者
Berdine Martin
Research Scientist, Nutrition Science
Purdue University