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临床试验/NCT00682214
NCT00682214已完成1 期

Skeletal Muscle Strength Including Its Energy Metabolism, Bone Mineral Homeostasis and Th1/Th2 Cytokines Expression in Asian Indians With Chronic Hypovitaminosis D Before and After Oral Cholecalciferol Supplementation

Indian Council of Medical Research0 个研究点目标入组 40 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
主要终点
Improvement in peripheral muscle Muscle strength by Cholecalciferol supplementation as revealed by muscle power and Magnetic resonance spectroscopic study

研究概览

简要总结

Hypovitaminosis D is common in Asian Indians despite plenty of sunshine and relates to their skin pigmentation and poor sunshine exposure. Serum 25(OH)D levels are <20 ng /ml in up to 90% of them and therefore, based on the modern cut off, majority of apparently healthy normal Asian Indians would be classified as vitamin D deficient. Though, several investigators have highlighted the paradox of hypovitaminosis D in sunny Indian environment, there are only limited studies which have assessed its functional significance. To date, the significance of low serum 25(OH)D in them have been analyzed in terms of its inverse relationship with serum parathyroid hormone levels and variable association with reduced bone mineral content at hip and spine on DXA. Recently we have shown impairment in the absorption of intestinal calcium in 25(OH)D and its reversal after eight weeks of cholecalciferol supplementation. Present study is being taken to further understand the functional significance of 25(OH)D in terms of its effect on Skeletal muscle strength including its energy metabolism, bone mineral homeostasis and Th1/Th2 cytokines expression in Asian Indians with chronic biochemical hypovitaminosis D

详细描述

Vitamin D is an essential nutrient that plays an important role in calcium metabolism and bone health. In recent years, biomarkers like PTH, calcium absorption have been used to define relevant biological indices of vitamin D nutritional status.

Prevalence of 25(OH)D in Asian Indians Several studies from India have shown wide prevalence of vitamin D deficiency (VDD) in India, Goswami et al studied serum 25 (OH)D levels and its functional significance in apparently healthy subjects residing in Delhi. In this study three groups of subjects (soldiers, depigmented person and physicians and nurses) were studied in winter. Other three groups namely pregnant women, newborns and physicians and nurses were studied in summer. All the groups except one with maximum sunlight exposure (soldiers) had subnormal concentration of serum 25(OH) D levels. Vitamin D deficient groups tended to have an imbalance in bone mineral homeostasis when exposed to winter and low dietary calcium and high dietary phytate, with significantly low serum calcium and elevated PTH.On the basis of the studies related to the intestinal calcium absorption, inverse relation with serum iPTH concentration and protection from fracture risk, a recent consensus has suggested that an ideal health based normal cutoff of circulating serum 25(OH) D would at least be 32 ng/mL. Interestingly, using the above consensus, recent studies conducted at AIIMS, by Goswami et al , have shown that 94.3% of the apparently healthy northern Indian subjects residing in Delhi were vitamin D deficient (AJCN 2006, BJN 2008).

Functional Significance of 25(OH)D deficiency Though there have several studies highlighting widespread prevalence of 25(OH)D in Asian Indians, there is paucity of data on its functional significance. Relevant studies assessing functional significance of VDD in Asian Indians are summarized below (Am J Clin Nutr 2000).

A) Effects on Serum PTH levels Goswami et al while reporting low serum 25(OH) D concentrations in healthy subjects in Delhi, showed a higher serum PTH levels & significant inverse relation between serum 25(OH) D and PTH levels ( r = -0.6303, p < 0.001) in all the three groups (soldiers, physicians & nurses, depigmented persons) studied in winter (Am J Clin Nutr 2006) B) Effects on BMD Recently,we have analyzed relationship between BMD and serum 25(OH) D in 105 apparently healthy Asian Indian. The cohort of 105 subjects was split into 2 groups at a serum 25(OH) D cutoff of 9.0 ng/mL. The mean serum iPTH was significantly higher in the group 1 (<9.0 ng/ml)than in the group 2 subjects (53.1±31.3 and 39.3±17.5 pg/mL, respectively; P=0.012).The mean BMD values of the total hip, including femoral neck, trochanter, and intertrochanter, were significantly (P = 0.001) lower in group 1 than in group 2.

C) Effects on intestinal calcium absorption Effect of VDD on intestinal calcium absorption in Asian Indians with chronic hypovitaminosis D and its change after cholecalciferol supplementation was studied recently at our Department of Endocrinology and Metabolism. Study subjects were 29 apparently healthy volunteers [17 M, 12 F, mean (SD) age = 28.4 ± 6.4 year] with low serum 25(OH)D levels [mean (SD) = 7.6 ± 4.8 ng/ml]. Intestinal calcium absorption was assessed by 'calcium load test' (PAK test) (10) using 1 gm of oral elemental calcium load before and after (n = 26) supplementation with oral cholecalciferol (60,000 IU/week for eight weeks). This study showed that the vitamin D Deficiency is physiologically relevant in terms of intestinal calcium absorption in Asian Indians.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 20 years
  • Residence of Delhi
  • Commitment for follow-up at 8 weeks, 6 months & 1 year.
  • Consent for 8 weeks of supplementation

排除标准

  • Subjects taking drugs, which can affect bone mineral metabolism such as glucocorticoids, antitubercular, antiepileptics, levothyroxine, bisphosphonates
  • Chronic renal or liver disorder
  • Chronic diarrhea

研究组 & 干预措施

A, Choelcalciferol

Active Comparator

Drug: Cholecalciferol 60,000 IU sachet and calcium carbonate Oral cholecalciferol (vitamin D)60,000 IU weekly along with daily oral dose of 1 gm calcium carbonate for first two months followed by 1 gm of elemental calcium in form of calcium carbonate daily cholecalciferol (vitamin D)60,000 IU per month for the next four months

干预措施: Cholecalciferol (Drug)

B, Lactose

Placebo Comparator

干预措施: Lactose placebo (Drug)

结局指标

主要结局

Improvement in peripheral muscle Muscle strength by Cholecalciferol supplementation as revealed by muscle power and Magnetic resonance spectroscopic study

时间窗: Six months

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

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