Vitamin D Supplementation in Estonian Conscripts

NCT04939636 | Completed

• 1 other identifier: 323/T-3
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

A longitudinal, double-blinded, randomized, trial, with a 10 month follow-up period will be conducted between July 2021 to May 2022

Conditions

Vitamin D Deficiency; Military Activity; Physical Stress

Keywords

Vitamin D supplementation; Conscripts; Military sevice; Physical preformance

Outcome Measures

Primary Outcomes (4)

• Prevalence of vitamin D between study groups (Baseline, no intervention)

  Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if \<75 nmol/L, deficient if \<50 nmol/L and critical deficiency \< 25 nmol/L.

  0 months Baseline

• Prevalence of vitamin D between study groups (Intervention I vs.II)

  Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if \<75 nmol/L, deficient if \<50 nmol/L and critical deficiency \< 25 nmol/L.

  3 months

• Prevalence of vitamin D between study groups (Intervention I vs.II)

  Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if \<75 nmol/L, deficient if \<50 nmol/L and critical deficiency \< 25 nmol/L.

  app.6-7 months

• Prevalence of vitamin D between study groups (Intervention I vs.II)

  Prevalence of vitamin D measured serum vitamin D 25(OH)D concentration. Vitamin D considered as sufficient if the serum 25(OH)D concentration is ≥75 nmol/L, insufficient if \<75 nmol/L, deficient if \<50 nmol/L and critical deficiency \< 25 nmol/L.

  app. 9-10 months

Secondary Outcomes (61)

• Serum parathyroid hormone

  0 months baseline

• Serum parathyroid hormone

  3 months

• Serum parathyroid hormone

  app. 6-7 months

• Serum parathyroid hormone

  app. 9-10 months

• Serum calcium

  0 months baseline

Study Arms (2)

Vitamin D3 capsules 4000IU/100µg

ACTIVE COMPARATOR

Get Vitamin D3 capsules 4000IU/100µg.

Dietary Supplement: Vitamin D3 capsules 4000IU/100µg.

Vitamin D3 capsules 600IU/15µg

ACTIVE COMPARATOR

Get Vitamin D3 capsules 600IU/15µg.

Dietary Supplement: Vitamin D3 capsules 600IU/15µg.

Interventions

Vitamin D3 capsules 4000IU/100µg. DIETARY_SUPPLEMENT

Vitamin D3 supplementation

Vitamin D3 capsules 4000IU/100µg

Vitamin D3 capsules 600IU/15µg. DIETARY_SUPPLEMENT

Vitamin D3 supplementation

Vitamin D3 capsules 600IU/15µg

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participating in military service at the Estonian Defence Forces
• Voluntary participation in the study

You may not qualify if:

• Refusal of a conscript or withdrawal of consent
• Departure from military unit
• Force majeure
• Acute trauma or illness in the course of conscript requiring hospital treatment
• Serious side effects or allergies to vitamin D capsules

Sponsors & Collaborators

• Tartu University Hospital: lead
• Estonian Defence Forces: collaborator
• University of Tartu: collaborator

Study Sites (1)

Kuperjanov Infantry Battalion, Estonian Defence Forces

Võru, Võrumaa, 50400, Estonia

Location

Related Publications (18)

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  PMID: 17344510 BACKGROUND

• Inklebarger J, Griffin M, Taylor MJ, Dembry RB. Femoral and tibial stress fractures associated with vitamin D insufficiency. J R Army Med Corps. 2014 Mar;160(1):61-3. doi: 10.1136/jramc-2013-000085. Epub 2013 Jun 26.

  PMID: 24109098 BACKGROUND

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  PMID: 24706237 BACKGROUND

• Kull M Jr, Kallikorm R, Tamm A, Lember M. Seasonal variance of 25-(OH) vitamin D in the general population of Estonia, a Northern European country. BMC Public Health. 2009 Jan 19;9:22. doi: 10.1186/1471-2458-9-22.

  PMID: 19152676 BACKGROUND

• Laaksi IT, Ruohola JP, Ylikomi TJ, Auvinen A, Haataja RI, Pihlajamaki HK, Tuohimaa PJ. Vitamin D fortification as public health policy: significant improvement in vitamin D status in young Finnish men. Eur J Clin Nutr. 2006 Aug;60(8):1035-8. doi: 10.1038/sj.ejcn.1602414. Epub 2006 Feb 15.

  PMID: 16482069 BACKGROUND

• Laaksi I, Ruohola JP, Tuohimaa P, Auvinen A, Haataja R, Pihlajamaki H, Ylikomi T. An association of serum vitamin D concentrations < 40 nmol/L with acute respiratory tract infection in young Finnish men. Am J Clin Nutr. 2007 Sep;86(3):714-7. doi: 10.1093/ajcn/86.3.714.

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• Ruohola JP, Laaksi I, Ylikomi T, Haataja R, Mattila VM, Sahi T, Tuohimaa P, Pihlajamaki H. Association between serum 25(OH)D concentrations and bone stress fractures in Finnish young men. J Bone Miner Res. 2006 Sep;21(9):1483-8. doi: 10.1359/jbmr.060607.

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MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Madis Rahu, PhD

  University of Tartu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Computed randomization will be used to divide conscripts into two groups; the intervention group, who received vitamin D3 capsules (4000 IU/100µg) or the intervention group, who received vitamin D3 capsules (600 IU/15µg) .
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, Orthopaedic surgeon

Model Details: Triple blinded randomized placebo-controlled study

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: June 25, 2021
• Study Start: July 19, 2021
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)