Early Czech Periconceptional Supplementation Studies

In a large, (but non-randomized) prospective interventional trial by Dr. Marie Tolarova among a sample of the Czech population, it was shown that periconceptional supplementation with multivitamins and 10 mg of folic acid reduced the recurrence risk for cleft lip with or without cleft palate (CL/P) by about 65%. (“Periconceptional” describes the 2 months before & 3 months after conception.)

Findings

  • Decrease of recurrences by 65.4% in supplemented pregnancies with the proband with CL/P.
  • Decrease of recurrences by 82.6% in the subset of supplemented pregnancies with the proband with unilateral CL/P.
  • No change of recurrence in the subset of supplemented pregnancies with female proband with bilateral CL/P.

Methods

Supplemented Group

  • N=221 mothers with positive family history
  • 133 previous child affected with CL or CL/P
  • 88 affection is prospective mother or father

Non-supplemented Group

  • N=1,901 mothers with positive family history
  • 1,046 previous child affected with CL or CL/P
  • 855 affection in prospective mother or father

Protocol

  • Genetic evaluation and physicals – proband and 1st degree relatives
  • Risk of recurrence
  • Medical examination of prospective mothers
  • treatment
  • optimal time of conception recommended
  • living conditions considered
  • periconceptional supplementation
  • all mothers seen every month
  • newborns examined

Supplementation Regimen

  • Folic Acid (10 mg daily given in one tablet)
  • Spofavit (multivitamin preparation given as 3 tablets daily)
  • 1 tablet contains:
    Vitamin A 2000 IU
    Vitamin B1 1 mg
    Vitamin B2 1 mg
    Vitamin B6 1 mg
    Vitamin C 50 mg
    Vitamin D3 100 IU
    Vitamin E 2 mg
    Nicotinamide 10 mg
    Calcium Panthotenicum 1 mg