Clinical trial NCT02922803: Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
Official title: Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Vitamin D Deficiency
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: S-25-hydroxyvitamin D in nmol/L.
timeFrame: 10 months
measure: Grip strength in Newton.
timeFrame: 10 months
measure: Upper leg strength, able or not able to squat
timeFrame: 10 months
Secondary outcomes:
measure: Trendelenburg's sign positive or not. not.
timeFrame: 10 months
measure: Sit to stand five times, able or not.
timeFrame: 10 months
measure: Standing on one leg 30 seconds, able or not
timeFrame: 10 months
Other outcomes:
Locations:
city: Borlänge
country: Sweden
facility: Primary Health care center Jakobsgårdarna
state: Dalecarlia
Study officials:
affiliation: Uppsala University
name: Paul Kalliokoski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University
name: Monica Löfvander, Ass. Prof.
role: STUDY_DIRECTOR
References:
citation: Kalliokoski P, Bergqvist Y, Lofvander M. Physical performance and 25-hydroxyvitamin D: a cross-sectional study of pregnant Swedish and Somali immigrant women and new mothers. BMC Pregnancy Childbirth. 2013 Dec 17;13:237. doi: 10.1186/1471-2393-13-237.
citation: Kalliokoski P, Widarsson M, Rodhe N, Lofvander M. Positive impact on vitamin D related lifestyle of medical advice in pregnant Somali-born women and new mothers: a mixed method study in Swedish primary care. BMC Public Health. 2021 Feb 5;21(1):297. doi: 10.1186/s12889-021-10277-y.
citation: Kalliokoski P, Rodhe N, Bergqvist Y, Lofvander M. Long-term adherence and effects on grip strength and upper leg performance of prescribed supplemental vitamin D in pregnant and recently pregnant women of Somali and Swedish birth with 25-hydroxyvitamin D deficiency: a before-and-after treatment study. BMC Pregnancy Childbirth. 2016 Nov 15;16(1):353. doi: 10.1186/s12884-016-1117-3.