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临床试验/NCT02922803
NCT02922803已完成不适用

Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women

Uppsala University1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
123
试验地点
1
主要终点
S-25-hydroxyvitamin D in nmol/L.

研究概览

简要总结

Somali migrant women, often in veiled clothing, living in a town in mid Sweden on the 60:th parallel were observed to be weak and to have a waddling gate.

Study 1 was carried out in the setting of an antenatal clinic administered from a primary care center in Borlänge, a Swedish middle-sized industrial town at the 60:th parallel in Sweden. The investigators chose an initial study period in late spring to reflect the effects of the dark season with little ultraviolet B radiation that affects vitamin D production. Study 1 was carried out in a short period of time. The recruitment was performed in a retrospective design in order to neglect the seasonal effects of ultraviolet B radiation. Study 1 was carried out in year 2010. It was a cross sectional baseline study of blood levels of vitamin D measured as 25-hydroxyvitamin D (25-OHD) and physical performance in 123 pregnant and new mothers from Somalia (n=52) and Sweden (n=71).

Study 2: Examines the results on muscular performance, i.e. grip strength and squatting ability, from intervention with advice and prescription of vitamin D3 and calcium for 10 months, in all the women from study 1 with 25-OHD levels <50 nmol/L or 50 nmol/L of 25-OHD.

Study 3: The recruitment to Study 1 also serves as recruitment for a cohort study on delivery outcome in birth protocols starting 2016.

Study 4: The aim is to study the emic perspective and lifestyle related to vitamin D and strength in the group of Somali women by focus interviews among the Somali women from above.

A possible fifth study will explore correlations between 25-OHD and pain distribution and pain parameters.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant or new mother from Sweden or Somalia living in Borlänge and registered the antenatal clinic in Borlänge maximally 21 months prior to study start.

排除标准

  • Severe metabolic, medical or mental disease (ex. deranged type I diabetes or psychosis).

研究组 & 干预措施

Vitamin D insufficient

Active Comparator

Subjects with Vitamin D level in blood > 25 nmool/L < 50 nmol/L will be treated with 1 combination tablet of Vitamin D3/calcium per day

干预措施: 1 combination tablet of Vitamin D3/calcium per day (Drug)

Vitamin D deficient

Active Comparator

Subjects with Vitamin D level in blood < 25 nmol/L (25-OHD) will be treated with 2 combination tablets of Vitamin D3/calcium per day

干预措施: 2 combination tablets of Vitamin D3/calcium per day (Drug)

结局指标

主要结局

S-25-hydroxyvitamin D in nmol/L.

时间窗: 10 months

Grip strength in Newton.

时间窗: 10 months

Upper leg strength, able or not able to squat

时间窗: 10 months

次要结局

  • Trendelenburg's sign positive or not. not.(10 months)
  • Standing on one leg 30 seconds, able or not(10 months)
  • Sit to stand five times, able or not.(10 months)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Kalliokoski

MD

Uppsala University

研究点 (1)

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