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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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ClinicalTrials.gov Identifier: NCT02922803
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Paul Kalliokoski, Uppsala University

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.


Condition or disease Intervention/treatment Phase
Muscle Weakness Vitamin D Deficiency Drug: 1 combination tablet of Vitamin D3/calcium per day Drug: 2 combination tablets of Vitamin D3/calcium per day Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vitamin D and Physical Performance Before and After Intervention and Birth Outcome in Pregnant Somali and Swedish Women
Study Start Date : May 2010
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

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 Name: 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 Name: 2 tablets Kalcipos D Forte




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922803


Locations
Sweden
Primary Health care center Jakobsgårdarna
Borlänge, Dalecarlia, Sweden, 87110
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Paul Kalliokoski, MD Uppsala University
Study Director: Monica Löfvander, Ass. Prof. Uppsala University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Kalliokoski, MD, Uppsala University
ClinicalTrials.gov Identifier: NCT02922803     History of Changes
Other Study ID Numbers: DVITOS2
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Vitamin D Deficiency
Muscle Weakness
Paresis
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents