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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02922803
• Other study ID #: DVITOS2
• Status: Completed
• Phase: N/A
• First received: September 28, 2016
• Last updated: September 30, 2016
• Start date: May 2010
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis
• Vitamin D Deficiency

Intervention

Drug:
• 1 combination tablet of Vitamin D3/calcium per day
Combination tablet of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
• 2 combination tablets of Vitamin D3/calcium per day
Combination tablets of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)

Locations

Country	Name	City	State
Sweden	Primary Health care center Jakobsgårdarna	Borlänge	Dalecarlia

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Kalliokoski P, Bergqvist Y, Löfvander 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S-25-hydroxyvitamin D in nmol/L.		10 months	No
Primary	Grip strength in Newton.		10 months	No
Primary	Upper leg strength, able or not able to squat		10 months	No
Secondary	Trendelenburg's sign positive or not. not.		10 months	No
Secondary	Sit to stand five times, able or not.		10 months	No
Secondary	Standing on one leg 30 seconds, able or not		10 months	No