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Trial record 93 of 123 for:    hypertension "vitamin d"

D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life (D-tect)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03330301
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
The Danish Council for Strategic Research
Information provided by (Responsible Party):
Berit Lilienthal Heitmann, Bispebjerg Hospital

Brief Summary:

Vitamin D deficiency is common among otherwise healthy pregnant women and may have consequences for them as well as the early development and long-term health of their children. However, the importance of maternal vitamin D status has not been widely studied.

The present study is divided into a societal experiment (1) and a case-cohort study (2):

  1. The present study includes an in-depth examination of the influence of exposure to vitamin D early in life and during critical periods of growth for development of type 1 diabetes (T1D), type 2 diabetes, gestational diabetes, pre-eclampsia, obesity, asthma, arthritis, cancer, mental and cognitive disorders, congenital disorders, dental caries and bone fractures during child- and adulthood. The study is based on the fact that mandatory fortification of margarine with vitamin D, which initiated in 1937, was terminated in 1985.

    Apart from determining the influences of exposure prior to conception and during pre- and postnatal life, the investigators examined the importance of vitamin D exposure during specific seasons and trimesters, by comparing disease incidence among individuals born before and after the fortification.

  2. Additionally, a validated method was used to determine neonatal vitamin D status using stored dried blood spots (DBS) from individuals who develop the aforementioned disease entities as adults and their time and gender-matched controls.

Unparalleled, the study will help determine the effects of vitamin D exposure during critical periods in life. There are a sufficient number of individuals to verify any effects during different gestation phases and seasons of the year. The results, which will change our current understanding of the significance of vitamin D, will enable new research in related fields, including interventional research designed to assess supplementation needs for different subgroups of pregnant women. Also, other health outcomes can subsequently be studied to generate multiple new interdisciplinary health research opportunities involving vitamin D.


Condition or disease Intervention/treatment
Vitamin D Deficiency Obesity Diabetes Mellitus Pre-Eclampsia Arthritis Asthma Bone Fracture Tooth Diseases Birth Weight Birth Disorder Pregnancy Complications Mental Disorder Cancer Congenital Disorders Other: D-tect

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Study Type : Observational [Patient Registry]
Actual Enrollment : 222776 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 33 Years
Official Title: D-tecting Disease - From Exposure to Vitamin D During Critical Periods of Life
Actual Study Start Date : April 1, 2012
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
Exposed
  1. Individuals born between June1983 and May1985 were exposed to the mandatory vitamin D margarine fortification during fetal life.
  2. Cases: individuals defined as having one of the aforementioned diseases of interest from the registers
Other: D-tect
  1. This study is based on a unique Danish social experiment that took place during a well-defined period between 1937 and December 1985, when it was mandatory to fortify all margarine with vitamin D (1.25 μg/100 g). This well-defined vitamin D fortification period makes it possible to investigate the impact of fetal exposure to extra vitamin D from food fortification on the risk of developing diseases later on. This study is possible due not only to the well-defined adjacent time window but also to the complete registration of every citizen via a civil registration number. This number can be linked, on an individual level, to Danish birth, patient and medical registries; social and ethnic registries; and clinical and other large databases
  2. Case-cohort study: vitamin D measurements from dried blood spots and the risk of diseases later on

Non-exposed
  1. Individuals born between September1986 and August 1988 were not exposed to the mandatory vitamin D margarine fortification during fetal life.
  2. Controls: cohort of matched disease-free individuals
Other: D-tect
  1. This study is based on a unique Danish social experiment that took place during a well-defined period between 1937 and December 1985, when it was mandatory to fortify all margarine with vitamin D (1.25 μg/100 g). This well-defined vitamin D fortification period makes it possible to investigate the impact of fetal exposure to extra vitamin D from food fortification on the risk of developing diseases later on. This study is possible due not only to the well-defined adjacent time window but also to the complete registration of every citizen via a civil registration number. This number can be linked, on an individual level, to Danish birth, patient and medical registries; social and ethnic registries; and clinical and other large databases
  2. Case-cohort study: vitamin D measurements from dried blood spots and the risk of diseases later on




Primary Outcome Measures :
  1. Obesity [ Time Frame: 2012-2025 ]
    Register based

  2. Type 1 diabetes [ Time Frame: 2012-2016 ]
    Register based

  3. Pre-eclampsia [ Time Frame: 2012-2025 ]
    Register based

  4. Bone facture [ Time Frame: 2012-2025 ]
    Register based


Secondary Outcome Measures :
  1. Type 2 diabetes [ Time Frame: 2014-2025 ]
    Register based

  2. Gestational diabetes [ Time Frame: 2014-2025 ]
    Register based

  3. Asthma [ Time Frame: 2015-2025 ]
    Register based

  4. Arthritis [ Time Frame: 2018-2025 ]
    Register based

  5. Birth weight [ Time Frame: 2014-2019 ]
    Register based

  6. Mental diseases [ Time Frame: 2012-2025 ]
    Register based


Other Outcome Measures:
  1. Cancers [ Time Frame: 2018-2025 ]
    Register based

  2. Mental disorders [ Time Frame: 2018-2025 ]
    Register based

  3. Dental caries [ Time Frame: 2018-2025 ]
    Register based

  4. Congenital disorders [ Time Frame: 2018-2025 ]
    Register based



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

Entire Danish population born between June1983-May1985 and September 1986-August 1988.

For the part of the study using vitamin D measurements from DBS:

The Danish Civil registration system was used to identify all live-born children during 1981-2002 (n = 1,360,466), and a random subcohort thereof was sampled for 25(OH)D analyses to be used across the D-tect studies (n = 3585)

Criteria

Inclusion Criteria:

  1. Born in Denmark around the fortification period
  2. Sufficient amount of blood from the DBS

Exclusion Criteria:

1.Born outside Denmark

  1. Born outside the fortification period
  2. Insufficient amount of blood from the DBS or DBS not found

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): NCT03330301


Locations
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Denmark
Parker Institute
Frederiksberg, Denmark, 2000
Sponsors and Collaborators
Bispebjerg Hospital
The Danish Council for Strategic Research

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Berit Lilienthal Heitmann, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03330301     History of Changes
Other Study ID Numbers: 0603-00453B
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamin D Deficiency
Hypertension, Pregnancy-Induced
Vitamin D
Disease
Diabetes Mellitus
Birth Weight
Mental Disorders
Psychotic Disorders
Eclampsia
Pre-Eclampsia
Pregnancy Complications
Fractures, Bone
Tooth Diseases
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight
Signs and Symptoms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Wounds and Injuries
Stomatognathic Diseases
Vitamins
Ergocalciferols
Micronutrients
Nutrients