A Randomised Comparative Trial of two different bolus doses of Vitamin D given to lactating mother on serum Vitamin D levels of their infants.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To Compare the effectiveness of two different single bolus doses(120000IU and 60000IU)of maternal Vitamin D supplementation on Vitamin D status of their breastfeeding infants at 30 days.
研究概览
简要总结
Breastfeeding is the optimal source of nutrition for infants under 6 months of age.However there are concerns that breastfeeding infants may not maintain adequate Vitamin D status from thneir mother’s millk.This is in part contributed by low maternal Vitamin D levels, and limited exposure of infant to sunlight.It is a widely accepted fact that Vitamin D levels are low in breast milk.The bony condition resulting from Vitamin D defeciency is nutritional Rickets.AAP recommends supplementation of breastfed infants with Vitamin D at 400IU/d,beginning in first few days of life.Although this has been the recommendation for decadesit is rarely followed for various reasons,poor compliance being the most common one,resulting in significant risk of Vitamin D defeciency in the nursing infants.Various studies have found that single monthly supplementation is as effective as daily supplementation given to mother in improving both maternal and infant Vitamin D status.Keeping this in mind we have planned this RCT to find out the improvement in Vitamin D status of breast feeding infants when it is given to their lactating mothers in single bolus dose of 120000 and 60000 IU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 30.00 Day(s)（—）
- 性别
- All
入选标准
- •Healthy exclusively breastfed mother infant pairs(single term infants with weight more than 2 kg)within 1 month of delivary who will be willing to follow up after 1 month.
排除标准
- •Mothers with preexisting comorbidities(type 2 diabetes,hypertension,chronic renal or liver disease),receiving antipsychotic drugs,clinical features suggestive of osteomalacia or severe Vitamin D deficiency,or exposure to medication known to interact with Vitamin D metabolism(steroids or anticonvulsants) Infants with congenital malformation,history of severe birth asphyxia Subjects with serum calcium more than 11mg/do,serum 25(OH)D level more than 100ng/ml,liver enzymes elevated more than 3 times of Upper limit normal and serum creatinine above upper limit normal for age.
结局指标
主要结局
To Compare the effectiveness of two different single bolus doses(120000IU and 60000IU)of maternal Vitamin D supplementation on Vitamin D status of their breastfeeding infants at 30 days.
时间窗: To Compare the effectiveness of two different single bolus doses(120000IU and 60000IU)of maternal Vitamin D supplementation on Vitamin D status of their breastfeeding infants at 30 days.
次要结局
- To find out the increase in maternal Vitamin D levels in mothers after 30 days of receiving Vitamin D supplementation of 120000IU or 60000IU as single dose(30 days)
- To study the proportion of Vitamin D deficiency in lactating mothers and their infants in a tertiary care hospital in a period of 12 months(12 months)