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Early Czech Studies (by Dr. Marie Tolarova)
In a large, but non-randomized prospective interventional trial among a sample of the Czech population, Tolarova showed that periconceptional supplementation with multivitamins and 10 mg of folic acid reduced the recurrence risk for cleft lip with or without cleft palate (CLąP) 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 CLP
- 88 affection is prospective mother or father
Nonsupplemented Group
- N=1,901 mothers with positive family history
- 1,046 previous child affected with CL or CLP
- 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 |
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