Comparative Assessment of Methylcobalamin and Ascorbic acid on Cognitive Function in Post-Menopausal Women - A Randomized, Double-blind Trial
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Vitamin B12 and Vitamin C Effects on Cognitive Function will be studied
研究概览
简要总结
The present study was designed to compare the effect of Methylcobalaminand ascorbic acid on cognitive function in post-menopausal women. An assessmentof cognitive function was conducted using MMSE tests and serum β-amyloid42levels. The MMSE is a modified screening tool used to evaluate cognitivedeficits and assessments are simple and can be applied in primary health carewith low cost.
Nosignificant differences were observed between ascorbic acid and methylcobalamingroups in a number of reported adverse events, and no subjects were removedfrom the study for a treatment-related adverse event.
InSummary, the present study provides evidence that ascorbic acid showedimprovement in cognitive function among post-menopausal women when compared tomethylcobalamin supplement. It is our hope that this preliminary data will beutilized to design large-scale longer-term trials with similar objectives in post-menopausalwomen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •MMSE Score 21-24
- •Menopausal women (taken as complete cessation of menstruation for at least 1 year/12 cycles) who had attained menopause for a period extending over 4 – 10 years at the time of inclusion into the study.
排除标准
- •MMSE Score 25-30
- •History of recent or current Estrogen or hormonal replacement therapy
- •Known hypertensive, diabetic, renal disease, endocrine disorders, overt nutritional deficiency states, anemia, liver disease or those having history of psychiatric illness.
- •History of Women having estrogen secreting ovarian tumors, for e.g., granulosa and theca cell tumors, tumors of the adrenal gland.
- •Known history of neurological disorders including CVA, space occupying lesions, epilepsy and developmental anomalies.
- •Women, who are physically unable to hear, read or understand written or explained instructions properly, or may have a motor deficit that affects writing and drawing skills.
- •Women, who are already in any of the antioxidant or dietary supplement therapy.
结局指标
主要结局
Vitamin B12 and Vitamin C Effects on Cognitive Function will be studied
时间窗: Baseline, 45 days, 90 days
次要结局
- Relation between estrogen and cognitive function will be studied(Baseline, 45 days, 90 days)