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Completed

NCT Number: NCT02922803

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Primary Health care center Jakobsgårdarna

Borlänge, Dalarna County, 87110, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

1 combination tablet of Vitamin D3/calcium per day

Drug

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

Other names: 1 tablet Kalcipos D Forte

2 combination tablets of Vitamin D3/calcium per day

Drug

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

Other names: 2 tablets Kalcipos D Forte

Primary outcomes

  1. S-25-hydroxyvitamin D in nmol/L.

    Time frame: 10 months

  2. Grip strength in Newton.

    Time frame: 10 months

  3. Upper leg strength, able or not able to squat

    Time frame: 10 months

Secondary outcomes

  1. Trendelenburg's sign positive or not. not.

    Time frame: 10 months

  2. Sit to stand five times, able or not.

    Time frame: 10 months

  3. Standing on one leg 30 seconds, able or not

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Oct 4, 2016
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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