Iodocefol
Table of Contents
1 Iodocefol
1.1 Product Description
Iodocefol is a first of its kind product launched in India by Tzana Pharmaceuticals Pvt. Ltd. Iodocefol is a wholesome and comprehensive dietary supplement, addressing the additional nutritional requirements of pregnant and lactating women in a balanced and healthy manner. The product formulation and quality has been ensured through stringent quality checks and adherence to international quality standards during raw material procurement, manufacturing, packaging and distribution.
1.2 Product Composition
Each Iodocefol tablet contains approximately:
- Folic Acid: 400 mcg,
- Iodine: 200 mcg
- Vitamin B12: 2 mcg
1.3 Recommended Dosage
- Pregnant women during the first trimester and for one month before conception
- 1 tablet daily, administered before meal
1.4 Product Benefits
- Prevention of folic acid, iodine and Vitamin B12 deficiency disorders in pregnant women.
- Consuming one month before conception, Iodocefol prevents occurrence of neural tube defects and neurological disorders in the fetus.
- Promotes healthy growth and mental development of the fetus
- Better metabolism and mineral absorption for the mother
2 Folic Acid
2.1 Uses and Benefits
- Folic acid is a B type vitamin that helps body to produce and maintain new cells and helps prevent changes to DNA that may lead to cancer.
- Used to treat folic acid deficiency and certain types of anemia.
- Daily dosage of 400 mcg recommended to prevent Neural Tube Defects-affected pregnancy in women1
2.2 Naturally occurring sources
Folic acid occurs natually as folates. The recommended daily dosage of folates are 800 mcg.This can be replaced with 400 mcg of synthentic folic acid.2
Food | Serving | Amount of Folates |
---|---|---|
Spinach | 1/2 cup | 121-139 mcg |
Lentils | 3/4 cup | 265 mcg |
Black beans | 1 cup | 256 mcg |
Green Peas | 1 cup | 101 mcg |
Orange Juice | 1/2 cup | 25-39 mcg |
Avocado | 1/2 fruit | 81 mcg |
Okra (ladies finger) | 1/2 cup | 97 mcg |
Sunflower seeds | 1/4 cup | 82 mcg |
Liver (beef) | 75 g | 122 - 195 mcg |
2.3 Recommended daily dosage
- 400 micrograms of folic acid daily 3
The United States CDC goes further to recommend that all women between 15 and 45 years of age should consume folic acid daily because half of U.S. pregnancies are unplanned and because these birth defects occur very early in pregnancy (3-4 weeks after conception), before most women know they are pregnant.4
2.4 Effects of Folic Acid Deficiency
- Birth Weight and Gestation: Folate can influence fetal growth and gestation duration. Folate deficiency interferes with growth of the embryo in womb, maternal erythropoiesis growth of the uterus and mammary gland, and growth of the placenta.5
- Spontaneous Absorption and Fetal Demise: The frequency of Neural Tube defects among spontaneously aborted foetuses is 10-fold higher than is the rate of Neural tube defects at birth. Furthermore, there is a strong positive relation (r = 0.96) between rates of neural tube defects in pregnancies coming to term and rates of Neural tube defects among pregnancies terminating in spontaneous abortion. A rat model of folate deficiency suggests that severe gestational folate deficiency increases the risk of fetal demise whereas moderate folate deficiency does not, instead decrease DNA synthesis and reducing litter size and weight.6
2.5 Risks associated with over dosage of folic acid
- More than 1000 mcg of Folic Acid is not recommended.
- Overdose symptoms may include numbness or tingling, mouth or tongue pain, weakness, tired feeling confusion, or trouble concentrating.7
- Hypersensitivity reactions. Allergic reactions are common symptoms of folic acid overdose. Patients may experience swelling of the lips, tongue, mouth, itching, and development of hives on the skin
- Gastrointestinal disturbances. People suffering from folic acid overdose may also experience nausea, flatulence, distention of the abdomen, loss of appetite, and metallic taste in the mouth as signs of high levels of folic acid in the GIT.
- Insomnia. People usually have difficulty sleeping with feelings of hyperactivity, excitability, irritability and inability to concentrate as emotional symptoms of folic acid overdose.
- Cognitive disturbances. People may also experience psychotic behaviors and depression; however, it tends to be rare and occur in individuals with history of the conditions.
- Masking Vitamin B12 deficiency. Taking too much folic acid usually corrects the anemia that is caused by vitamin B12 deficiency without correcting the deficiency of vitamin B12. Because of this, health care providers may not be able to detect the presence of vitamin B12 deficiency because of being asymptomatic.
3 Iodine
3.1 Uses and Benefits
The body needs iodine but cannot make it. The needed iodine must come from the diet. Pregnancy induces increased demand on the maternal thyroid gland. Increased thyroid hormone production in pregnancy requires adequate iodine availability. Women typically begin pregnancy with 10-20 mg of iodine stored in the thyroid and, with continued sufficient iodine ingestion, are able to meet the increased demands of pregnancy. If adequate iodine is not available, TSH rises and consequently goiter develops.
The fetus and placenta also consume a proportion of maternal thyroid hormone and iodine. Once fetal thyroid gland function is established, fetal thyroidal turnover of iodine is much higher than adult. Therefore, the fetal iodine store—supported exclusively by maternal intake—must be continuously refreshed. 8
- Iodine is essential for the metabolism of the thyroid
- Development of cognitive abilities
- It is associated with lower risks of developing certain types of cancer.
- Iodine plays an important role in development of the central nervous system of the foetus during pregnancy
3.2 Sources of Iodine
3.2.1 Iodised salt
India has a mandatory salt iodization programme where each gram of salt is required to have 15 mcg of Iodine. We get most of the Iodine from Iodized salt. But during pregnancy the need for Iodine is much higher (250 mcg) than what is required for an average adult (150 mcg). Salt, however also comes with Sodium. About 3.75g of salt gives you 1500 mg of Sodium. Major health organizations like the one below recommend that we cut back on Sodium:
- United States Department of Agriculture (USDA): 2300 mg.
- American Heart Association (AHA): 1500 mg (2).
- Academy of Nutrition and Dietetics (AND): 1500 to 2300 mg.
- American Diabetes Association (ADA): 1500 to 2300 mg.
India's iodization program requires 15 mcg of Iodine per gram of salt. Thus 3.75 to 6 grams of salt gives you 90 mcg of Iodine and 2400 mcg of Sodium. If you keep the levels of Sodium under recommended dosages, supplementation for Iodine is required.
3.2.2 IDD despite iodisation
Studies have shown that despite the idodisation programme, only 48.9% 9 of the samples had required amount of iodine in them. This is despite NIDDCP lab tests certifying all brands of salt for their required iodine content. This meant that even when people were buying iodised salt, improper storage and cooking practices were leading to the loss of iodine from the salt, she said.
Another concern is with the presence of thiocyanates in our food is reducing the amount of iodine absorbed into the body. “Several studies have pointed out that the high consumption of tapioca, sweet potato and cabbage in the State could be one factor for the persisting prevalence of goitre despite the consumption of iodised salt. The thiocyanates in these foods can affect the absorption of iodine in the body,” U. Anuja, Assistant Professor, Department of Community Medicine, Medical College, said.
Salt iodization especially by small scale producers who contribute to approximately 66 per cent of total iodized salt production in the country is not of optimal quality. There are considerable variations in the levels of iodization, high moisture content of salt and use of improper packaging material leading to sub optimal iodine content of salt at consumer level10
3.2.3 Other sources
Other than fortified salt, the concentrations of iodine in these foods can vary widely and this table should be taken as a rough guide.11
Food | Serving Size | Iodine |
---|---|---|
Fish (Salmon, Tuna) | 100 g | 14 mcg |
Shellfish - Prawns | 60g | 6 mcg |
Eggs | 1 egg | 25 mcg |
Meat/Poultry | 100 g | 10 mcg |
Nuts | 25g | 5 mcg |
Bread | 1 slice | 5 mcg |
3.3 Recommended Dosage
Recommended Daily Intake. WHO recommends ingestion of approximately 250mcg iodine daily for pregnant and lactating women. The United States Institute of Medicine’s recommended daily allowance for iodine is 220mcg during pregnancy and 290mcg during lactation (Table 2) 12
Target | WHO recommended daily iodine intake | IOM recommended daily iodine intake |
---|---|---|
Adequate intake for nonpregnant adult | 150 mcg | 150 mcg |
Adequate intake in pregnant women | 250 mcg | 220 mcg |
Adequate intake for lactating women | 250 mcg | 290 mcg |
3.4 Effects of Iodine Deficiency
- It can lead to high blood pressure during pregnancy for the mother, and mental retardation for the baby.
- In extreme cases, iodine deficiency can lead to cretinism, a disorder that involves severely stunted physical and mental growth.
- Iodine deficiency and the resulting low levels of thyroid hormone can cause women to stop ovulating, leading to infertility.
- Iodine deficiency can also lead to an autoimmune disease of the thyroid and may increase the risk of getting thyroid cancer.
- Severe iodine deficiency is associated with neurological complications, cretinism, endemic goitre development, hypothyroidism, decreased fertility and increased infant mortality
- Decreased IQ scores in children whose mothers were mildly iodine deficient during pregnancy ( (Angela M. Leung, Oct 2014)
- Goitre and hypothyroidism in pregnant women affecting adversely the mental and fetal health.
- Even mild to moderate iodine deficiency may affect the cognitive and motor function of children.
Pregnancy induces increased demand on the maternal thyroid gland.
4 Vitamin B12
4.1 Uses and Benefits
- Vitamin B12 Cyanocobalamin is a man-made form of vitamin B12. Vitamin B12 is important for growth, cell reproduction, blood formation, and protein and tissue synthesis.
- Cyanocobalamin is used to treat vitamin B12 deficiency in people with pernicious anemia and other conditions.
4.2 Recommended Dosage
- Pregnant women: 2.6 mcg per day (Ref Table 3) 13
Intake recommendations for vitamin B12 and other nutrients are provided in the Dietary Reference Intakes (DRIs) developed by the Food and Nutrition Board (FNB) at the Institute of Medicine (IOM) of the National Academies (formerly National Academy of Sciences). DRI is the general term for a set of reference values used for planning and assessing nutrient intakes of healthy people. These values, which vary by age and gender, include: Recommended Dietary Allowance (RDA): average daily level of intake sufficient to meet the nutrient requirements of nearly all (97%–98%) healthy individuals. Adequate Intake (AI): established when evidence is insufficient to develop an RDA and is set at a level assumed to ensure nutritional adequacy. Tolerable Upper Intake Level (UL): maximum daily intake unlikely to cause adverse health effects.
Age | Male | Female | Pregnancy | Lactation |
---|---|---|---|---|
4 - 8 | 1.2 mcg | 1.2 mcg | ||
9 - 13 | 1.8 mcg | 1.8 mcg | ||
14+ | 2.4 mcg | 2.4 mcg | 2.6 mcg | 2.8 mcg |
4.3 Effects and Symptoms of Vitamin B12 deficiency
Vitamin B12 and folate perform several important functions in the body, including keeping the nervous system healthy. A deficiency in either of these vitamins can cause a wide range of problems, including:
- extreme tiredness
- a lack of energy
- pins and needles (paresthesia)
- a sore and red tongue
- mouth ulcers
- muscle weakness
- disturbed vision
- psychological problems, which may include depression and confusion
- problems with memory, understanding and judgement
Some of these problems can also occur if you have a deficiency in vitamin B12 or folate, but don't have anemia. Vitamin B12 or folate deficiency (with or without anemia) can lead to complications, particularly if you've been deficient in vitamin B12 or folate for some time. Potential complications can include:
- problems with the nervous system
- temporary infertility
- heart conditions
- pregnancy complications and birth defects
Adults with severe anemia are also at risk of developing heart failure. Some complications improve with appropriate treatment, but others like the problems with the nervous system can be permanent.
4.4 Naturally Occurring Food Sources
Non-vegetarians have plenty of sources for Vitamin B12 in their diet as shown in Table 4 14
Food | Per Serving |
---|---|
Clams, cooked, 3 ounces | 84.1 mcg |
Liver, beef, cooked, 3 ounces | 70.7 mcg |
Breakfast cereals, fortified with 100% of the DV for vitamin B12, 1 serving | 6.0 mcg |
Trout, rainbow, wild, cooked, 3 ounces | 5.4 mcg |
Salmon, sockeye, cooked, 3 ounces | 4.8 mcg |
Tuna fish, light, canned in water, 3 ounces | 2.5 mcg |
Cheeseburger, double patty and bun, 1 sandwich | 2.1 mcg |
Milk, low-fat, 1 cup | 1.2 mcg |
4.5 Risks associated with overdose of Vitamin B12
Researchers found that if a new mother has a very high level of folate right after giving birth—more than four times what is considered adequate—the risk that her child will develop a condition on the autism spectrum doubles. Very high vitamin B12 levels in new moms are also potentially harmful, tripling the risk that her offspring will develop an autism spectrum disorder. If both levels are extremely high, the risk that a child develops the condition increases 17.6 times. 15
5 Conclusion
"Adequate supplementation is protective: That's still the story with folic acid," says one of the study's senior authors, M. Daniele Fallin16, director of the School of Public Health's Wendy Klag Center for Autism and Developmental Disabilities. "We have long known that a folate deficiency in pregnant mothers is detrimental to her child's development. But what this tells us is that excessive amounts may also cause harm. We must aim for optimal levels of this important nutrient."
Research all over the world clearly demonstrates the benefits of having Folic Acid, Iodine and Vitamin B12 for pregnant mothers. However there is increasingly more research pointing to the fact that the recommended daily allowance of these vitamins needs to be adhered to for a healthy mother and child.
Iodocefol is a carefully conceptualized product that provides the daily recommended dosage for Folic Acid, Iodine and Vitamin B12. It has balance of formulation. The combination is widely prescribed all over the world and now, Tzana Pharmaceuticals brings this global product to India for the very first time.
Footnotes:
The Food and Nutrition Board of the National Academy of Sciences Institute of Medicine (IOM) https://www.nap.edu/read/10490/chapter/1
Food Sources of Folate by Dieticians of Canada https://www.dietitians.ca/Your-Health/Nutrition-A-Z/Vitamins/Food-Sources-of-Folate.aspx
US Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/folicacid/recommendations.html
US Centers for Disease Control and Prevention. https://www.cdc.gov/ncbddd/folicacid/recommendations.html
Folic acid: influence on the outcome of pregnancy (http://ajcn.nutrition.org/content/71/5/1295s.full.pdf+html)
Folic acid: influence on the outcome of pregnancy (http://ajcn.nutrition.org/content/71/5/1295s.full.pdf+html)
Drugs.com (https://www.drugs.com/folic_acid.html)
Iodine and Pregnancy by Christina Yarrington and Elizabeth N. Pearce in Journal of Thyroid research (http://dx.doi.org/10.4061/2011/934104) https://www.hindawi.com/journals/jtr/2011/934104/abs/
Iodine deficiency disorders a major health concern http://www.thehindu.com/todays-paper/tp-national/tp-kerala/Iodine-deficiency-disorders-a-major-health-concern/article15330070.ece
Karmarkar MG, Pandav CS, Yadav K, Kumar R. ‘Mission Approach’ to achieve sustainable elimination of iodine deficiency disorders (IDD) in India. World Journal of Endocrine Surgery Jaypee Brother Medical Publishers (P) Ltd. http://www.jaypeejournals.com/eJournals/ShowText.aspx?ID=3226&Type=FREE&TYP=TOP&IN=_eJournals/images/JPLOGO.gif&IID=248&isPDF=YES
The Association of UK dietitians - https://www.bda.uk.com/foodfacts/Iodine.pdf
Iodine and Pregnancy by Christina Yarrington and Elizabeth N. Pearce https://www.hindawi.com/journals/jtr/2011/934104/abs/
Vitamin B12 Dietary Supplement Fact Sheet https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/
Vitamin B12 Dietary Supplement Fact Sheet https://ods.od.nih.gov/factsheets/VitaminB12-HealthProfessional/
Too much folate in pregnant women increases autism risk https://hub.jhu.edu/2016/05/12/too-much-folate-pregnant-autism/
Margaret Daniele Fallin, PhD Chair, Department of Mental Health, https://www.jhsph.edu/faculty/directory/profile/967/margaret-daniele-fallin