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

Primary Purpose

Muscle Weakness, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
1 combination tablet of Vitamin D3/calcium per day
2 combination tablets of Vitamin D3/calcium per day
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Weakness

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Primary Health care center Jakobsgårdarna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vitamin D insufficient

Vitamin D deficient

Arm Description

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

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

Outcomes

Primary Outcome Measures

S-25-hydroxyvitamin D in nmol/L.
Grip strength in Newton.
Upper leg strength, able or not able to squat

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2016
Last Updated
September 30, 2016
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT02922803
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness, Vitamin D Deficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D insufficient
Arm Type
Active Comparator
Arm Description
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
Arm Title
Vitamin D deficient
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
1 combination tablet of Vitamin D3/calcium per day
Other Intervention Name(s)
1 tablet Kalcipos D Forte
Intervention Description
Combination tablet of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
Intervention Type
Drug
Intervention Name(s)
2 combination tablets of Vitamin D3/calcium per day
Other Intervention Name(s)
2 tablets Kalcipos D Forte
Intervention Description
Combination tablets of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
Primary Outcome Measure Information:
Title
S-25-hydroxyvitamin D in nmol/L.
Time Frame
10 months
Title
Grip strength in Newton.
Time Frame
10 months
Title
Upper leg strength, able or not able to squat
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Trendelenburg's sign positive or not. not.
Time Frame
10 months
Title
Sit to stand five times, able or not.
Time Frame
10 months
Title
Standing on one leg 30 seconds, able or not
Time Frame
10 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Kalliokoski, MD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monica Löfvander, Ass. Prof.
Organizational Affiliation
Uppsala University
Official's Role
Study Director
Facility Information:
Facility Name
Primary Health care center Jakobsgårdarna
City
Borlänge
State/Province
Dalecarlia
ZIP/Postal Code
87110
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24345271
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.
Results Reference
result
PubMed Identifier
33546641
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.
Results Reference
derived
PubMed Identifier
27846821
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.
Results Reference
derived

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

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