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

September 30, 2016 updated by: Paul Kalliokoski, Uppsala University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Dalecarlia
      • Borlänge, Dalecarlia, Sweden, 87110
        • Primary Health care center Jakobsgårdarna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 2 tablets Kalcipos D Forte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
S-25-hydroxyvitamin D in nmol/L.
Time Frame: 10 months
10 months
Grip strength in Newton.
Time Frame: 10 months
10 months
Upper leg strength, able or not able to squat
Time Frame: 10 months
10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Trendelenburg's sign positive or not. not.
Time Frame: 10 months
10 months
Sit to stand five times, able or not.
Time Frame: 10 months
10 months
Standing on one leg 30 seconds, able or not
Time Frame: 10 months
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Paul Kalliokoski, MD, Uppsala University
  • Study Director: Monica Löfvander, Ass. Prof., Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (ESTIMATE)

October 4, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 4, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DVITOS2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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