Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
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|ClinicalTrials.gov Identifier: NCT02922803|
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Muscle Weakness Vitamin D Deficiency||Drug: 1 combination tablet of Vitamin D3/calcium per day Drug: 2 combination tablets of Vitamin D3/calcium per day||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Active Comparator: Vitamin D insufficient
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
Drug: 1 combination tablet of Vitamin D3/calcium per day
Combination tablet of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
Other Name: 1 tablet Kalcipos D Forte
Active Comparator: Vitamin D deficient
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
Drug: 2 combination tablets of Vitamin D3/calcium per day
Combination tablets of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
Other Name: 2 tablets Kalcipos D Forte
- S-25-hydroxyvitamin D in nmol/L. [ Time Frame: 10 months ]
- Grip strength in Newton. [ Time Frame: 10 months ]
- Upper leg strength, able or not able to squat [ Time Frame: 10 months ]
- Trendelenburg's sign positive or not. not. [ Time Frame: 10 months ]
- Sit to stand five times, able or not. [ Time Frame: 10 months ]
- Standing on one leg 30 seconds, able or not [ Time Frame: 10 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922803
|Primary Health care center Jakobsgårdarna|
|Borlänge, Dalecarlia, Sweden, 87110|
|Principal Investigator:||Paul Kalliokoski, MD||Uppsala University|
|Study Director:||Monica Löfvander, Ass. Prof.||Uppsala University|