One Softgel contains: Vitamin D3 (as Cholecalcifreol) 5,000 IU • certified organic Coconut Oil 100 mg. Other Ingredients: Softgel Capsule (Gelatin, Glycerin, USP purified Water).
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Below is general information about the effectiveness of the known ingredients contained in the product Vitamin D3. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Vitamin D3. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally in food amounts. Coconut oil can be safely consumed as a component of the diet (12361,17935,94452,106494). However, coconut oil should not be considered a healthy alternative to other saturated fats (94453,94643). Coconut oil contains more saturated fat than animal based fats, including lard and butter (94643). Therefore, like all saturated fats, coconut oil should be used in moderation (94453,94643). ...when used topically and appropriately. Commercial products containing coconut oil in concentrations up to 100% have been used with apparent safety. However, most research has used commercial products with concentrations up to 70% (12356,17936,17941).
POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts, short-term. Taking coconut oil up to 10 mL orally two or three times daily for up to 12 weeks has been used with apparent safety in clinical research (17938,17942,90615,106493).
CHILDREN: POSSIBLY SAFE
when used topically and appropriately, short-term.
Coconut oil has been used with apparent safety in children and neonates for about one month (13483,17937,90614,90616,96204,101873). There is insufficient reliable information available about the safety of coconut oil when taken orally in children.
PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of using coconut oil in medicinal amounts during pregnancy or lactation.
Coconut oil ingestion increases the amount of lauric acid in breast milk within 10 hours. This indicates that fatty acids from coconut oil are rapidly transferred into human breast milk following oral intake (14086). The impact of this increase in lauric acid on nursing infants is not known.
LIKELY SAFE ...when used orally or intramuscularly and appropriately. Vitamin D has been safely used in a wide range of doses (7555,16888,16891,17476,95913,98186,104619,105209,109059). When used orally long-term, doses should not exceed the tolerable upper intake level (UL) of 4000 IU (100 mcg) daily for adults (17506,99773); however, much higher doses such as 50,000 IU (1250 mcg) weekly orally for 6-12 weeks are often needed for the short-term treatment of vitamin D deficiency (16891,17476). Monthly oral doses of up to 60,000 IU (1500 mcg) have also been safely used for up to 5 years (105726). Toxicity usually does not occur until plasma levels exceed 150 ng/mL (17476).
POSSIBLY UNSAFE ...when used orally in excessive doses, long-term. Taking doses greater than the tolerable upper intake level (UL) of 4000 IU (100 mcg) daily for long periods can increase the risk of hypercalcemia (17506); however, much higher doses are often needed for short-term treatment of vitamin D deficiency. Toxicity typically occurs when levels exceed 150 ng/mL (17476).
CHILDREN: LIKELY SAFE
when used orally and appropriately.
When used long-term, doses should not exceed the tolerable upper intake level (UL) of 1000 IU (25 mcg) daily for those 0-6 months of age, 1500 IU (37.5 mcg) daily for those 6-12 months of age, 2500 IU (62.5 mcg) daily for those 1-3 years of age, 3000 IU (75 mcg) daily for those 4-8 years of age, and 4000 IU (100 mcg) daily for those 9 years and older (17506); however, much higher doses are often needed for the short-term treatment of vitamin D deficiency. Some research shows that giving vitamin D 14,000 IU (350 mcg) weekly for a year in children aged 10-17 years is safe (16875). A meta-analysis of clinical studies shows that 1000 IU (25 mcg) daily in those up to a year of age and greater than 2000 IU (50 mcg) daily in those aged 1-6 years does not increase the risk of serious adverse events (108424).
CHILDREN: POSSIBLY UNSAFE
when used orally in excessive doses for longer than one year.
Taking doses greater than the tolerable upper intake level (UL) long-term can increase the risk of hypercalcemia (17506).
PREGNANCY: LIKELY SAFE
when used orally and appropriately.
Vitamin D is safe when used in doses below the tolerable upper intake level (UL) of 4000 IU (100 mcg) daily (17506,95910).
PREGNANCY: POSSIBLY UNSAFE
when used orally in excessive amounts.
Tell patients not to use doses above the tolerable upper intake level (UL) of 4000 IU (100 mcg) daily. Hypercalcemia during pregnancy due to excessive vitamin D intake can lead to several fetal adverse effects, including suppression of parathyroid hormone, hypocalcemia, tetany, seizures, aortic valve stenosis, retinopathy, and mental and/or physical developmental delay (17506).
LACTATION: LIKELY SAFE
when used orally and appropriately.
Vitamin D is safe when used in doses below the tolerable upper intake level (UL) of 4000 IU (100 mcg) daily (17506).
LACTATION: POSSIBLY UNSAFE
when used orally in excessive amounts.
Tell patients not to use doses above the tolerable upper intake level (UL) of 4000 IU (100 mcg) daily (17506).
Below is general information about the interactions of the known ingredients contained in the product Vitamin D3. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Vitamin D might increase aluminum absorption and toxicity, but this has only been reported in people with renal failure.
Details
The protein that transports calcium across the intestinal wall can also bind and transport aluminum. This protein is stimulated by vitamin D, which may therefore increase aluminum absorption (11595,11597,22916). This mechanism may contribute to increased aluminum levels and toxicity in people with renal failure, when they take vitamin D and aluminum-containing phosphate binders chronically (11529,11596,11597).
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Vitamin D might reduce absorption of atorvastatin.
Details
A small, low-quality clinical study shows that taking vitamin D reduces levels of atorvastatin and its active metabolites by up to 55%. However, while atorvastatin levels decreased, total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol levels did not substantially change (16828). Atorvastatin is metabolized in the gut by CYP3A4 enzymes, and researchers theorized that vitamin D might induce CYP3A4, causing reduced levels of atorvastatin. However, this proposed mechanism was not specifically studied.
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Taking calcipotriene with vitamin D increases the risk for hypercalcemia.
Details
Calcipotriene is a vitamin D analog used topically for psoriasis. It can be absorbed in sufficient amounts to cause systemic effects, including hypercalcemia (15). Theoretically, combining calcipotriene with vitamin D supplements might increase the risk of hypercalcemia.
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Vitamin D might induce CYP3A4 enzymes and reduce the bioavailability of CYP3A4 substrates.
Details
There is some concern that vitamin D might induce CYP3A4. In vitro research suggests that vitamin D induces CYP3A4 transcription. Additionally, observational research has found that increased UV light exposure and serum vitamin D levels are associated with decreased serum levels of CYP3A4 substrates such as tacrolimus and sirolimus, while no association between UV light exposure or vitamin D levels and levels of mycophenolic acid, a non-CYP3A4 substrate, was found (110539). A small, low-quality clinical study shows that taking vitamin D reduces levels of the CYP3A4 substrate atorvastatin and its active metabolites by up to 55%; however, the clinical effects of atorvastatin were not reduced (16828). While researchers theorized that vitamin D might induce CYP3A4, this proposed mechanism was not specifically studied.
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Theoretically, hypercalcemia induced by high-dose vitamin D can increase the risk of arrhythmia from digoxin.
Details
High doses of vitamin D can cause hypercalcemia. Hypercalcemia increases the risk of fatal cardiac arrhythmias with digoxin (15). Avoid vitamin D doses above the tolerable upper intake level (4000 IU daily for adults) and monitor serum calcium levels in people taking vitamin D and digoxin concurrently.
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Theoretically, hypercalcemia induced by high-dose vitamin D can reduce the therapeutic effects of diltiazem for arrhythmia.
Details
High doses of vitamin D can cause hypercalcemia. Hypercalcemia can reduce the effectiveness of verapamil in atrial fibrillation (10574). Theoretically this could also occur with diltiazem. Avoid vitamin D doses above the tolerable upper intake level (4000 IU daily for adults) and monitor serum calcium levels in people taking vitamin D and diltiazem concurrently.
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Theoretically, taking thiazide diuretics and high-dose vitamin D can increase the risk of hypercalcemia.
Details
Thiazide diuretics decrease urinary calcium excretion, which could lead to hypercalcemia if vitamin D supplements are taken concurrently (3072,11541,69580). This has been reported in people being treated with vitamin D for hypoparathyroidism, and also in elderly people with normal parathyroid function who were taking a thiazide, vitamin D, and calcium-containing antacids daily (11539,11540).
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Hypercalcemia induced by high-dose vitamin D can reduce the therapeutic effects of verapamil for arrhythmia.
Details
Hypercalcemia due to high doses of vitamin D can reduce the effectiveness of verapamil in atrial fibrillation (10574). Avoid vitamin D doses above the tolerable upper intake level (4000 IU daily for adults) and monitor serum calcium levels in people taking vitamin D and verapamil concurrently.
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Below is general information about the adverse effects of the known ingredients contained in the product Vitamin D3. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General
...Orally and topically, coconut oil is generally well tolerated.
Most Common Adverse Effects:
Orally: Increased cholesterol levels.
Serious Adverse Effects (Rare):
All routes of administration: Allergic reactions, including anaphylaxis, in sensitive individuals.
Cardiovascular ...Due to its high saturated fat content, there has been some speculation that consuming coconut oil might increase cholesterol levels and the risk of cardiovascular disease. Several population and clinical studies have found that consuming coconut oil increases total cholesterol, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol in some patients (12361,14407,17935,17940,94451,94452,99103,101877,101879,106489,106494). In patients with normal to high cholesterol levels, consuming a daily diet providing 30% to 36% of calories from fat, of which 46% to 66% is from coconut oil, for 4-12 weeks increases total cholesterol by about 12-15 mg/dL, low-density lipoprotein (LDL) cholesterol by about 9-12 mg/dL, and HDL cholesterol by 3-6 mg/dL when compared to a diet containing vegetable oils, especially those rich in polyunsaturated fatty acids (17935,94451,94452,101877,106489). In some cases, these cholesterol effects are similar to those seen in patients consuming a similar diet containing butter or beef fat (12361,17935,94451,99103,101879). Despite the potential effects of coconut oil on cholesterol levels, population research has not found an association with coconut oil consumption and risk of adverse cardiovascular events such as myocardial infarction or angina (14407,96205). Advise patients not to rely on coconut oil as a "healthy" alternative to other saturated fats.
Dermatologic ...In one case report, a 6-year-old child developed urticaria and hives from applying coconut oil to the skin. The child had been exposed to coconut oil consistently since 2 weeks of age, indicating sensitization over the course of regular exposure (95806). In clinical research, one patient reported localized pruritus immediately after applying a combination of coconut oil, anise oil, and ylang ylang (13483). It is unclear if this event was due to coconut oil, other ingredients, or the combination. Also, it is possible that this was an idiosyncratic event.
Gastrointestinal ...Orally, diarrhea and gastroenteritis have been reported rarely (101877).
Hepatic ...Orally, taking virgin coconut oil in the diet for 28 days modestly increased levels of liver enzymes in patients with coronavirus disease 2019 (COVID-19). However, it is unclear if this was due to the coconut oil or to the illness (107664).
Immunologic
...Several cases of allergic reactions have been reported for patients who consumed coconut fruit.
In some of the cases, the patients were previously diagnosed with sensitivity to other tree nuts, including peanuts, so cross-sensitivity is suspected. In a separate case report, a 17-year-old male was found to be sensitized to both coconut and buckwheat, indicating a possible cross-sensitivity between the two allergens (95808). In other cases, the patients did not show sensitivity to any other allergens, so the patients were considered to have a single allergy to coconut fruit (12359,12360).
Because coconut oil is derived from coconut fruit, ingestion of coconut oil may theoretically cause allergic reactions in patients with confirmed allergy to coconut fruit. In one case report, a 6-year-old child who had previously experienced urticaria and hives from applying coconut oil to the skin experienced throat swelling and anaphylaxis after eating food containing coconut, indicating a sensitivity to both the fruit and the oil via both topical application and ingestion (95806). However, allergic reactions to coconut appear to occur significantly less often than allergies to other food items such as wheat, milk, soy, or peanut (14408).
General
...Orally or intramuscularly, vitamin D is well tolerated.
Serious Adverse Effects (Rare):
Orally or intramuscularly: Excessive doses can lead to vitamin D toxicity with symptoms of hypercalcemia, and also sometimes azotemia and anemia.
Cardiovascular ...Vitamin D intoxication can occur when vitamin D supplements are taken orally in excessive doses. Rarely, people develop hypertension (10142). An analysis of clinical research suggests that, when taken orally, vitamin D might modestly increase levels of low-density lipoprotein (LDL)-cholesterol. However, it is not clear if this increase is clinically significant (84642).
Gastrointestinal ...Orally, vitamin D may cause dry mouth. In clinical research, intake of vitamin D 50,000 IU weekly for 4 weeks followed by 50,000 IU monthly for 5 months thereafter was associated with a 3.7-fold increase in reports of dry mouth compared with placebo (91348).Vitamin D intoxication can occur when vitamin D supplements are taken orally in excessive doses. Symptoms of vitamin D toxicity include pancreatitis (10142,84433). Vomiting occurred in one patient given a single dose of 200,000 IU (104624).
Genitourinary ...Vitamin D intoxication can occur when vitamin D supplements are taken orally in excessive doses. Advanced symptoms may include decreased libido (10142). Vaginal discharge and itching have been reported in a clinical trial following oral use (91348).
Hematologic
...Lab values of urinary and blood calcium, phosphate, albumin, blood urea nitrogen, serum cholesterol, aspartate aminotransferase, and alanine aminotransferase concentrations might increase with vitamin D use, especially with high doses (10142,91349,93943).
A case of elevated international normalized ration (INR) has been reported for an 84 year-old patient who took vitamin D 50,000 IU daily for 2 months. The patient's serum levels of vitamin D increased from <7 ng/mL to 100 ng/mL over 6 months. To resolve symptoms, vitamin D supplementation was discontinued (84433).
Musculoskeletal ...Vitamin D intoxication can occur when vitamin D supplements are taken in excessive doses (10142,17506). Symptoms of vitamin D toxicity include osteoporosis in adults and decreased growth in children (10142).
Ocular/Otic ...Vitamin D intoxication can occur when vitamin D supplements are taken orally in excessive doses (10142,17506). Symptoms of vitamin D toxicity include calcific conjunctivitis and photophobia (10142).
Psychiatric ...Vitamin D intoxication can occur when vitamin D supplements are taken orally in excessive doses (10142,17506). In rare cases, symptoms of vitamin D toxicity include psychosis (10142,93002).
Pulmonary/Respiratory ...Vitamin D intoxication can occur when vitamin D supplements are taken orally in excessive doses. Advanced symptoms of vitamin D toxicity may include runny nose (10142,17506,93002).
Renal ...Vitamin D intoxication can occur when vitamin D supplements are taken orally in excessive doses. Symptoms of vitamin D toxicity include azotemia. Vitamin D may also cause hypercalcemia, with advanced symptoms including kidney stones or kidney insufficiency due to precipitation of calcium phosphate in the tubules. Symptoms of renal impairment include frequency, nighttime awakening to urinate, thirst, inability to concentrate urine, and proteinuria. Renal impairment is usually reversible with discontinuation of vitamin D supplements (10142,93002,93943,110831,110833).