Skeletal Muscle Strength,Bone Mineral Homeostasis and Th1 and Th2 Cytokines Expression in Asian Indians With Chronic Hypovitaminosis D Before and After Oral Cholecalciferol Supplementation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 170
- 主要终点
- Improvement in Muscle strength
研究概览
简要总结
Vitamin D deficiency is widely prevalent in India. Serum 25(OH)D levels are <20 ng /ml in up to 90% of them. Recently, in a randomized control trial, investigators have shown that dual cholecalciferol and calcium supplementation lead to significant improvement in hand grip strength and distance covered during six minutes walk test. 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 surface electromyography (EMG) in a larger cohort involving approximately 200 subjects. The impact of calcium and vitamin D supplementation would be assessed by supplementing them alone and in combination. Besides, the investigators would also assess impact of above supplementation on Th1/Th2 cytokines expression in the peripheral mononuclear cells.
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. 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 and showed low serum 25(OH)D values in all the groups (Am J Clin Nutr 2000). Its functional significance is currently under evaluation.
Relevant studies assessing functional significance of VDD in Asian Indians are summarized below (Am J Clin Nutr 2000).
A) 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) 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 (Journal of Human Nutrition and dietetics 2010).
Recently in a randomized control trial we have shown significant improvement in the muscle strength and walking distance after dual supplementation with cholecalciferol and calcium (Clin Endocrinol 2010). In the current study we plan to study this aspect further by recruiting four groups to study the effect of calcium and vitamin D supplementation alone or in combination as a dual supplementation. Baseline evaluation (Before vitamin D supplementation) would include serum total calcium, inorganic phosphorus, alkaline phosphatase, intact PTH and 25(OH) D assays, hand grip muscle strength and surface EMG testing. Hand grip would be done will be done using a computerized dynamometer in the Department of Physical Medicine and Rehabilitation under the guidance of Professor U Singh, Head, Department of Physical Medicine & Rehabilitation, AIIMS. Handgrip strength will be measured in right hand by dynamometer. The average of two measurement of grip strength will be used for analysis (in kg).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or more
- •Residence of Delhi
- •Commitment for follow-up at 8 weeks, 6 months.
- •Consent for 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
cholecalciferol
cholecalciferol 60,000IU/week for first eight weeks followed by 60,000 IU every 15 days for four months along with calcium placebo
干预措施: Cholecalciferol (Drug)
cholecalciferol
cholecalciferol 60,000IU/week for first eight weeks followed by 60,000 IU every 15 days for four months along with calcium placebo
干预措施: Calcium Carbonate (Drug)
cholecalciferol
cholecalciferol 60,000IU/week for first eight weeks followed by 60,000 IU every 15 days for four months along with calcium placebo
干预措施: cholecalciferol and calcium carbonate (Drug)
cholecalciferol
cholecalciferol 60,000IU/week for first eight weeks followed by 60,000 IU every 15 days for four months along with calcium placebo
干预措施: lactose granules and tablets (Other)
Calcium carbonate
two tablets of calcium carbonate daily equivalent to 1 gm of elemental calcium for six months along with vitamin D placebo
干预措施: Calcium Carbonate (Drug)
Calcium carbonate
two tablets of calcium carbonate daily equivalent to 1 gm of elemental calcium for six months along with vitamin D placebo
干预措施: cholecalciferol and calcium carbonate (Drug)
Calcium carbonate
two tablets of calcium carbonate daily equivalent to 1 gm of elemental calcium for six months along with vitamin D placebo
干预措施: lactose granules and tablets (Other)
oral calcium and cholecalciferol
60,000 IU of cholecalciferol every week for ist eight week and then 60,000IU every 15 days for next four months along with 1 gm of elemental calcium ever day for six months
干预措施: cholecalciferol and calcium carbonate (Drug)
oral calcium and cholecalciferol
60,000 IU of cholecalciferol every week for ist eight week and then 60,000IU every 15 days for next four months along with 1 gm of elemental calcium ever day for six months
干预措施: lactose granules and tablets (Other)
lactose
identical placebos
干预措施: lactose placebo (Other)
lactose
identical placebos
干预措施: lactose granules and tablets (Other)
结局指标
主要结局
Improvement in Muscle strength
时间窗: six months
To assess change in upper and lower limb muscle strength by measiung hand grip, walking distance during six months of supplemnation with oral calcium carbonate alone, oral cholecalciferol alone, and dual supplemenation with oral cholecalciferol and calcium carbonate
次要结局
未报告次要终点
