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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02922803
Enrollment
123
Registered
2016-10-04
Start date
2010-05-31
Completion date
2016-08-31
Last updated
2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Weakness, Vitamin D Deficiency

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.

Interventions

DRUG1 combination tablet of Vitamin D3/calcium per day

Combination tablet of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)

DRUG2 combination tablets of Vitamin D3/calcium per day

Combination tablets of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
S-25-hydroxyvitamin D in nmol/L.10 months
Grip strength in Newton.10 months
Upper leg strength, able or not able to squat10 months

Secondary

MeasureTime frame
Trendelenburg's sign positive or not. not.10 months
Sit to stand five times, able or not.10 months
Standing on one leg 30 seconds, able or not10 months

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026