Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT02922803
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2016-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
Sponsor:
Uppsala University
Organization:
Study Overview
Official Title:
Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: